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Various Pharma jobs in Paraxel in Nov 2012

By: Job Search | Views: 801 | Date: 04-Nov-2012

Multiple vacancies in Parexel,Opening for Drug Safety Specialist, Senior Clinical Database Programmer, Customer Care Representative, Medical Research Reviewer, Drug Safety Physician, Drug Safety Associate

Multiple vacancies in Parexel | Require Drug Safety Specialist, Senior Clinical Database Programmer, Customer Care Representative, Medical Research Reviewer, Drug Safety Physician, Drug Safety Associate

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.

Post: 

  • Drug Safety Specialist
  • Senior Clinical Database Programmer
  • Customer Care Representative
  • Medical Research Reviewer
  • Drug Safety Physician
  • Drug Safety Associate

Position: Drug Safety Specialist

Job Description: 

Essential Function
The Drug Safety Specialist will provide technical and process-related expertise to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).

Relationships
Reports To Regional Head of PV Operations/Team Manager PV Operations
Directly Supervises None
Provides Work Direction to Drug Safety Assistants, Drug Safety Associates
Works Closely with All Medical and PV staff, Project Management and members of the Clinical Operations Group
External Relationships Clients, Healthcare Professionals, Consumers, Consumer Representatives, Regulatory Authorities, Central Ethics Committees

Key Accountabilities

* Develop project specific safety reporting procedures and workflows and provide guidance to the team on the procedures
* Develop project specific safety database customization and data entryguidelines
* Triage of incoming reports for completeness, legibility and validity
* Initial data entry of case reports into safety database / tracking system
* Assessment of case reports for seriousness, causality and expectedness
* Requesting follow-up i.e. written, telephone
* Adverse event (AE) and drug coding
* Writing case narratives
* Case reconciliation * coordinating activities with Data Management personnel
* Line listing and tabulation generation for safety reports i.e. periodic safety reports, ad hoc safety reports etc
* Quality control of case reports, line listings and tabulations
* Maintaining local drug safety reporting requirements
* Regulatory authority reporting (electronic and hard copy)
Literature reviews
* Ad hoc requests / queries
* Provide drug safety and project specific training
* Quality Assurance activities such as preparing for audits, development of templates, checklists and guidelines
* Create and maintain project specific working files, case report files and project central files
* Inform Medical Project Managers and Regional Head of PV Operations of potential change-in-scope of projects.
* Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities such as:
o drafting, writing and editing of protocols and CRFs
o collection and review of endpoint packages
o review and follow-up laboratory alerts
o review and follow-up patient eligibility for inclusion / exclusion in clinical trials
o review and follow-up protocol violations
o preparing relevant procedures covering the above medical monitoring activities
o review study specific Model ICFs according ICH/GCP criteria
* Act as the Medical Monitoring Representative in project teams, as appropriate
* Participate in client meetings / investigator meetings/ project specific training sessions
* Delegate work as appropriate to Drug Safety Associates and Drug Safety Assistants

Skills
* Sound knowledge of drug safety and the drug development process
* Knowledge of and ability to interpret and apply global safety regulations.
* Experience in data analysis and evaluation of safety data
* Demonstrated competence in processing, evaluating and reporting safety information in compliance with the regulations
* Good presentation skills
* Excellent interpersonal skills
* Excellent verbal / written communication skills
* Good time management skills
* Team player
* Client focused approach to work
* Experience with computer applications including database management and pharmacovigilance related computing systems

Candidate Profile: 
Education (one of:)
* Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification
* Associates/diploma degree in any of the above with appropriate work experience

Language Skills
* Fluent English

Experience:
* Drug safety knowledge and two years of experience experience in Safety Database
* Experience in working in drug development and/or healthcare environment

Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 10th Nov, 2012
Req Number: pare-10022353

Position: Senior Clinical Database Programmer

Job Description:
Essential Function
The Senior Clinical Database Programmer provides technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to clinical systems, and/or theapplications/systems within eClinical technologies. In addition, the Senior Clinical Database Programmer can fill the Database Primary role on projects, and liaise with sponsors, Data Operations Leader, and other functional areas as required. There are two specific functions that may be filled by the Senior Clinical Database Programmer, dependent on skill sets and experience; Clinical Systems and Support Programmer and Database Programmer. Relationships Reports To Manager, or above Directly Supervises N/A Provides Work Direction to Clinical Database Programmer I & II, Technical Analysts, Other members of the GRO department as appropriate Works Closely with Technical Analysts and Statistical Programmers, Data Processing, Biostatistics, Data Operations Leaders, QMG, RRC, Medical Writing, IT, Proposals and Business Development External Relationships Sponsors, Third Party Vendors, Auditors

Candidate Profile: 
Key Accountabilities
* Deliver best value and high quality service.
* Ability to fill Database Primary role on projects. The Database Primary will:
o Provide input into and negotiate clinical programming timelines. Ensure that timelines are adhered to.
o Coordinate and lead a programming team to successful completion of a study within given timelines and budget.
o Actively assume activities on a project, as required.
o Monitor project resourcing and identify changes in scope.

Education
* First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience.

Language Skills
* Excellent English written and oral communication skills.
Minimum Work Experience
* Relevant Clinical Trial industry experience
* Experience working with at least one system used within the Clinical Trial process (e.g., SAS, CDMS, EDC (Inform, RAVE, DataLabs), CTMS, Medical Safety Reporting)

Experience:
6 years of experience in Statistical Programming, Tables, listings and Figures.

Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 10th Nov, 2012
Req Number: pare-10022109

Position: Customer Care Representative

Job Description: 
Essential Skills
- Provide users/clients prompt, friendly, courteous and helpful service for all supported projects.
- Properly document and update issues entered into the issue tracking tool and ensure the issues are worked to resolution or closure per the project SLA and/or CCC processes.
- Resolve product/project related issues with assistance of CCC Manager, Senior Support Specialist, and Support Product Lead and/or Support Team Lead.
- Conduct system monitoring for supported Perceptive products/projects.
- Perform administrative tasks including, but not limited to data entry, sending out correspondence, and filing.
- Travel to alternate work location in the event of a disaster.
- Assist with shift coverage for all shifts.
- Ability to work a rotating shift to cover weekends as scheduled by the CCC Manager.
College Degree with 2 years experience in voice based call center. from an Inbound call center a plus.

Experience: 3 - 4 yrs. of experience in inbound International Call Center (Voice based).

Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 10th Nov, 2012
Req Number: pare-10022628

Position: Medical Research Reviewer

Job Description: Provide expert medical interpretations on imaging-related projects where imaging is used to evaluate the safety or efficacy of an investigational drug or device.

Candidate Profile:
M.D. or DNB (or country specific equivalent) in radiology, One year clinical practice or research is preferred but not required.

Experience with imaging clinical research is desirable.

Prior experience in a business environment desirable.

Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 10th Nov, 2012
Req Number: pare-10022374

Position: Drug Safety Physician

Job Description:
Essential Function

* Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products
* Ongoing safety surveillance and signal detection/analysis
* Provide medical guidance to Drug Safety Associates and Specialists in medical aspects of drug safety
* Provide medical input in all required safety reports, such as *but not limited to * PSURs, Clinical Expert Statement, Investigator notification letters
* Review all documents assigned for scientifically relevant issues including drug safety
* Function as pharmacovigilance representative/safety leader/senior technicallead on the projects, in Proposal Development Team and/or client meetings
* Provide medical advice and support for the safety component of feasibility studies
* Provide safety input to Risk-Management Plans, Pharmacovigilance Strategy and to the overall analysis of the benefit-risk balance of marketed or investigational products
* Support of Medical Directors as required
* Support of the QPPV

Relationships
Reports To Head of PV Operations
Directly Supervises None
Provides Work Direction to Drug Safety staff
Works Closely with All Medical and PV staff, PAREXEL Consulting (PC), Research Regulatory Compliance (RRC), Medical Writing Services (MWS), Proposal & Development Group (PDG), Project Management and members of the Clinical Operations Group
External Relationships Clients, Healthcare Professionals, Consumers, Consumer Representatives, Regulatory Authorities, Central Ethics Committees

Key Accountabilities
* Medical and scientific Pharmacovigilance review of:
o Literature Reports including epidemiological background research
Clinical trial reports
o Study protocols
o Clinical Trial (Serious) Adverse Event Reports
o Post-marketing ADR reports
o Case files, narratives, coding, causality and expectedness assessment
* Analysis of Adverse Event Reports during ongoing surveillance and signal detection, including independent analysis of safety risks
* Writing of safety section, including benefit risk assessment, of PSURs, Clinical Expert Statements and other documents as required; general PSUR support
* Provide medical guidance to Safety Staff during the case processing cycle
* Review and sign off technical documents written by PAREXEL with respect to medically relevant matters with particular attention to those relating to drug safety
* Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)
* Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
* Participate in Proposal Development Teams (PDTs) for client bid meetings
* Maintain up-to-date knowledge of projects by attending Professional SocietyMeetings
* Provide support for marketing activities as requested
* Provide medical safety expertise to client per request
* Provide medical safety expertise and training to other PAREXEL personnel, as required
* Be able to provide a 24 hours/day, 7 days/week availability per request
* Maintain a current medical license.
* Keep current with professional and pharmacovigilance regulations and knowledge
* Accommodate Pharmacovigilance timelines through flexible approach to working hours

Skills
* Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
* Clinical Research (GCP) or Pharmacovigilance knowledge /qualifications
* Computer skills
* Good knowledge of drug safety and the drug development process
* Good presentation skills
* Good interpersonal skills
* Good verbal / written communication skills
* Good time management skills
* Client focused approach to work

Candidate Profile: 
Education
* Physician (MBBS)
* Medically qualified in an acknowledged Medical School with completion of at least a basic training in clinical medicine (residency, internship etc.)

Language Skills
* Fluent English

Experience:
* Experience in Pharmaceutical Medicine desirable
* 1-2 years of PV experience preferred
* Clinical practice experience desirable

Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 10th Nov, 2012
Req Number: pare-10021439

Position: Drug Safety Physician

Job Description:
Essential Function

* Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products
* Ongoing safety surveillance and signal detection/analysis
* Provide medical guidance to Drug Safety Associates and Specialists in medical aspects of drug safety
* Provide medical input in all required safety reports, such as *but not limited to * PSURs, Clinical Expert Statement, Investigator notification letters
* Review all documents assigned for scientifically relevant issues including drug safety
* Function as pharmacovigilance representative/safety leader/senior technicallead on the projects, in Proposal Development Team and/or client meetings
* Provide medical advice and support for the safety component of feasibility studies
* Provide safety input to Risk-Management Plans, Pharmacovigilance Strategy and to the overall analysis of the benefit-risk balance of marketed or investigational products
* Support of Medical Directors as required
* Support of the QPPV

Relationships
Reports To Head of PV Operations
Directly Supervises None
Provides Work Direction to Drug Safety staff
Works Closely with All Medical and PV staff, PAREXEL Consulting (PC), Research Regulatory Compliance (RRC), Medical Writing Services (MWS), Proposal & Development Group (PDG), Project Management and members of the Clinical Operations Group
External Relationships Clients, Healthcare Professionals, Consumers, Consumer Representatives, Regulatory Authorities, Central Ethics Committees

Key Accountabilities
* Medical and scientific Pharmacovigilance review of:
o Literature Reports including epidemiological background research
Clinical trial reports
o Study protocols
o Clinical Trial (Serious) Adverse Event Reports
o Post-marketing ADR reports
o Case files, narratives, coding, causality and expectedness assessment
* Analysis of Adverse Event Reports during ongoing surveillance and signal detection, including independent analysis of safety risks
* Writing of safety section, including benefit risk assessment, of PSURs, Clinical Expert Statements and other documents as required; general PSUR support
* Provide medical guidance to Safety Staff during the case processing cycle
* Review and sign off technical documents written by PAREXEL with respect to medically relevant matters with particular attention to those relating to drug safety
* Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)
* Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
* Participate in Proposal Development Teams (PDTs) for client bid meetings
* Maintain up-to-date knowledge of projects by attending Professional SocietyMeetings
* Provide support for marketing activities as requested
* Provide medical safety expertise to client per request
* Provide medical safety expertise and training to other PAREXEL personnel, as required
* Be able to provide a 24 hours/day, 7 days/week availability per request
* Maintain a current medical license.
* Keep current with professional and pharmacovigilance regulations and knowledge
* Accommodate Pharmacovigilance timelines through flexible approach to working hours

Skills
* Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
* Clinical Research (GCP) or Pharmacovigilance knowledge /qualifications
* Computer skills
* Good knowledge of drug safety and the drug development process
* Good presentation skills
* Good interpersonal skills
* Good verbal / written communication skills
* Good time management skills
* Client focused approach to work

Candidate Profile: 
Education
* Physician (MBBS)
* Medically qualified in an acknowledged Medical School with completion of at least a basic training in clinical medicine (residency, internship etc.)

Language Skills
* Fluent English

Experience:
* Experience in Pharmaceutical Medicine desirable
* 1-2 years of PV experience preferred
* Clinical practice experience desirable

Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 10th Nov, 2012
Req Number: pare-10021439

Position: Drug Safety Physician

Job Description:
Essential Function

* Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products
* Ongoing safety surveillance and signal detection/analysis
* Provide medical guidance to Drug Safety Associates and Specialists in medical aspects of drug safety
* Provide medical input in all required safety reports, such as *but not limited to * PSURs, Clinical Expert Statement, Investigator notification letters
* Review all documents assigned for scientifically relevant issues including drug safety
* Function as pharmacovigilance representative/safety leader/senior technicallead on the projects, in Proposal Development Team and/or client meetings
* Provide medical advice and support for the safety component of feasibility studies
* Provide safety input to Risk-Management Plans, Pharmacovigilance Strategy and to the overall analysis of the benefit-risk balance of marketed or investigational products
* Support of Medical Directors as required
* Support of the QPPV

Relationships
Reports To Head of PV Operations
Directly Supervises None
Provides Work Direction to Drug Safety staff
Works Closely with All Medical and PV staff, PAREXEL Consulting (PC), Research Regulatory Compliance (RRC), Medical Writing Services (MWS), Proposal & Development Group (PDG), Project Management and members of the Clinical Operations Group
External Relationships Clients, Healthcare Professionals, Consumers, Consumer Representatives, Regulatory Authorities, Central Ethics Committees

Key Accountabilities
* Medical and scientific Pharmacovigilance review of:
o Literature Reports including epidemiological background research
Clinical trial reports
o Study protocols
o Clinical Trial (Serious) Adverse Event Reports
o Post-marketing ADR reports
o Case files, narratives, coding, causality and expectedness assessment
* Analysis of Adverse Event Reports during ongoing surveillance and signal detection, including independent analysis of safety risks
* Writing of safety section, including benefit risk assessment, of PSURs, Clinical Expert Statements and other documents as required; general PSUR support
* Provide medical guidance to Safety Staff during the case processing cycle
* Review and sign off technical documents written by PAREXEL with respect to medically relevant matters with particular attention to those relating to drug safety
* Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)
* Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
* Participate in Proposal Development Teams (PDTs) for client bid meetings
* Maintain up-to-date knowledge of projects by attending Professional SocietyMeetings
* Provide support for marketing activities as requested
* Provide medical safety expertise to client per request
* Provide medical safety expertise and training to other PAREXEL personnel, as required
* Be able to provide a 24 hours/day, 7 days/week availability per request
* Maintain a current medical license.
* Keep current with professional and pharmacovigilance regulations and knowledge
* Accommodate Pharmacovigilance timelines through flexible approach to working hours

Skills
* Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
* Clinical Research (GCP) or Pharmacovigilance knowledge /qualifications
* Computer skills
* Good knowledge of drug safety and the drug development process
* Good presentation skills
* Good interpersonal skills
* Good verbal / written communication skills
* Good time management skills
* Client focused approach to work

Candidate Profile: 
Education
* Physician (MBBS)
* Medically qualified in an acknowledged Medical School with completion of at least a basic training in clinical medicine (residency, internship etc.)

Language Skills
* Fluent English

Experience:
* Experience in Pharmaceutical Medicine desirable
* 1-2 years of PV experience preferred
* Clinical practice experience desirable

Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 10th Nov, 2012
Req Number: pare-10021439

Position: Drug Safety Physician

Job Description:
Essential Function

* Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products
* Ongoing safety surveillance and signal detection/analysis
* Provide medical guidance to Drug Safety Associates and Specialists in medical aspects of drug safety
* Provide medical input in all required safety reports, such as *but not limited to * PSURs, Clinical Expert Statement, Investigator notification letters
* Review all documents assigned for scientifically relevant issues including drug safety
* Function as pharmacovigilance representative/safety leader/senior technicallead on the projects, in Proposal Development Team and/or client meetings
* Provide medical advice and support for the safety component of feasibility studies
* Provide safety input to Risk-Management Plans, Pharmacovigilance Strategy and to the overall analysis of the benefit-risk balance of marketed or investigational products
* Support of Medical Directors as required
* Support of the QPPV

Relationships
Reports To Head of PV Operations
Directly Supervises None
Provides Work Direction to Drug Safety staff
Works Closely with All Medical and PV staff, PAREXEL Consulting (PC), Research Regulatory Compliance (RRC), Medical Writing Services (MWS), Proposal & Development Group (PDG), Project Management and members of the Clinical Operations Group
External Relationships Clients, Healthcare Professionals, Consumers, Consumer Representatives, Regulatory Authorities, Central Ethics Committees

Key Accountabilities
* Medical and scientific Pharmacovigilance review of:
o Literature Reports including epidemiological background research
Clinical trial reports
o Study protocols
o Clinical Trial (Serious) Adverse Event Reports
o Post-marketing ADR reports
o Case files, narratives, coding, causality and expectedness assessment
* Analysis of Adverse Event Reports during ongoing surveillance and signal detection, including independent analysis of safety risks
* Writing of safety section, including benefit risk assessment, of PSURs, Clinical Expert Statements and other documents as required; general PSUR support
* Provide medical guidance to Safety Staff during the case processing cycle
* Review and sign off technical documents written by PAREXEL with respect to medically relevant matters with particular attention to those relating to drug safety
* Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)
* Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
* Participate in Proposal Development Teams (PDTs) for client bid meetings
* Maintain up-to-date knowledge of projects by attending Professional SocietyMeetings
* Provide support for marketing activities as requested
* Provide medical safety expertise to client per request
* Provide medical safety expertise and training to other PAREXEL personnel, as required
* Be able to provide a 24 hours/day, 7 days/week availability per request
* Maintain a current medical license.
* Keep current with professional and pharmacovigilance regulations and knowledge
* Accommodate Pharmacovigilance timelines through flexible approach to working hours

Skills
* Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
* Clinical Research (GCP) or Pharmacovigilance knowledge /qualifications
* Computer skills
* Good knowledge of drug safety and the drug development process
* Good presentation skills
* Good interpersonal skills
* Good verbal / written communication skills
* Good time management skills
* Client focused approach to work

Candidate Profile: 
Education
* Physician (MBBS)
* Medically qualified in an acknowledged Medical School with completion of at least a basic training in clinical medicine (residency, internship etc.)

Language Skills
* Fluent English

Experience:
* Experience in Pharmaceutical Medicine desirable
* 1-2 years of PV experience preferred
* Clinical practice experience desirable

Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 10th Nov, 2012
Req Number: pare-10021439

Position: Drug Safety Physician

Job Description:
Essential Function

* Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products
* Ongoing safety surveillance and signal detection/analysis
* Provide medical guidance to Drug Safety Associates and Specialists in medical aspects of drug safety
* Provide medical input in all required safety reports, such as *but not limited to * PSURs, Clinical Expert Statement, Investigator notification letters
* Review all documents assigned for scientifically relevant issues including drug safety
* Function as pharmacovigilance representative/safety leader/senior technicallead on the projects, in Proposal Development Team and/or client meetings
* Provide medical advice and support for the safety component of feasibility studies
* Provide safety input to Risk-Management Plans, Pharmacovigilance Strategy and to the overall analysis of the benefit-risk balance of marketed or investigational products
* Support of Medical Directors as required
* Support of the QPPV

Relationships
Reports To Head of PV Operations
Directly Supervises None
Provides Work Direction to Drug Safety staff
Works Closely with All Medical and PV staff, PAREXEL Consulting (PC), Research Regulatory Compliance (RRC), Medical Writing Services (MWS), Proposal & Development Group (PDG), Project Management and members of the Clinical Operations Group
External Relationships Clients, Healthcare Professionals, Consumers, Consumer Representatives, Regulatory Authorities, Central Ethics Committees

Key Accountabilities
* Medical and scientific Pharmacovigilance review of:
o Literature Reports including epidemiological background research
Clinical trial reports
o Study protocols
o Clinical Trial (Serious) Adverse Event Reports
o Post-marketing ADR reports
o Case files, narratives, coding, causality and expectedness assessment
* Analysis of Adverse Event Reports during ongoing surveillance and signal detection, including independent analysis of safety risks
* Writing of safety section, including benefit risk assessment, of PSURs, Clinical Expert Statements and other documents as required; general PSUR support
* Provide medical guidance to Safety Staff during the case processing cycle
* Review and sign off technical documents written by PAREXEL with respect to medically relevant matters with particular attention to those relating to drug safety
* Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)
* Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
* Participate in Proposal Development Teams (PDTs) for client bid meetings
* Maintain up-to-date knowledge of projects by attending Professional SocietyMeetings
* Provide support for marketing activities as requested
* Provide medical safety expertise to client per request
* Provide medical safety expertise and training to other PAREXEL personnel, as required
* Be able to provide a 24 hours/day, 7 days/week availability per request
* Maintain a current medical license.
* Keep current with professional and pharmacovigilance regulations and knowledge
* Accommodate Pharmacovigilance timelines through flexible approach to working hours

Skills
* Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
* Clinical Research (GCP) or Pharmacovigilance knowledge /qualifications
* Computer skills
* Good knowledge of drug safety and the drug development process
* Good presentation skills
* Good interpersonal skills
* Good verbal / written communication skills
* Good time management skills
* Client focused approach to work

Candidate Profile: 
Education
* Physician (MBBS)
* Medically qualified in an acknowledged Medical School with completion of at least a basic training in clinical medicine (residency, internship etc.)

Language Skills
* Fluent English

Experience:
* Experience in Pharmaceutical Medicine desirable
* 1-2 years of PV experience preferred
* Clinical practice experience desirable

Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 10th Nov, 2012
Req Number: pare-10021439

Position: Drug Safety Associate

Job Description:
Essential Function

The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).

Relationships
Reports To Regional Head of PV Operations/ Associate Team Manager PV Operations Directly Supervises None
Provides Work Direction to Drug Safety Assistants
Works Closely with All Medical and PV staff, Project Management and members of the Clinical Operations Group
External Relationships Clients, Healthcare Professionals, Consumers, ConsumerRepresentatives

Key Accountabilities
* Triage of incoming reports for completeness, legibility and validity
* Initial data entry of case reports into safety database / tracking system
* Assessment of case reports for seriousness, causality and expectedness
* Requesting follow-up i.e. written, telephone
* Adverse event (AE) and drug coding
* Writing case narratives
* Create and maintain project specific working files, case report files and project central files
* Assist with additional Drug Safety Specialist activities as required
* Inform Medical Project Managers and Regional Head of PV Operations of potential change-in-scope of projects
* Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities such as:
o collection and review of endpoint packages
o review and follow-up laboratory alerts
o review and follow-up patient eligibility for inclusion / exclusion in clinical trials
o review and follow-up protocol violations
o review study specific Model ICFs according ICH/GCP criteria
* Participate in client meetings / investigator meetings / project specific training sessions
* Delegate work as appropriate to Drug Safety Assistants

Candidate Profile: 
Skills
* Understanding of drug safety and the drug development process
* Analytical and problem solving skills
* Excellent interpersonal skills
* Excellent verbal / written communication skills
* Time management skills
* Team player
* Client focused approach to work
* Experience with basic computer applications
Education (one of:)
* Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification
* Associates/diploma degree in any of the above with appropriate work experience

Language Skills
Fluent English

Experience:
Related experience gained in Pharmacovigilance or a healthcare environment

Additional Information:
Location: Andhra Pradesh - Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 10th Nov, 2012
Req Number: pare-10022352


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Various Pharma Jobs Walk-in at Central Drug Research Institute on 30th Nov 2012

Walkins | India | Pharma Jobs
Date:
24-Nov-2012  Views: 874

Multiple vacancies in Central Drug Research Institute | Project Assistant, Project Fellow, Junior Research Fellow, Senior Project Fellow, Project Rese ...
Opening for Pharma jobs in Nov/Dec 2012

Opening for Pharma jobs in Nov/Dec 2012

Openings | India | Pharma Jobs
Date:
06-Nov-2012  Views: 1462

Opening For the post of Jr. Scientist, Scientist I, II at National Institute of Biologicals, India in Nov/Dec 2012.Eligibility: M. Pharma (Pharmacolog ...
Pharma Jobs Openings November 2012

Pharma Jobs Openings November 2012

Openings | India | Pharma Jobs
Date:
03-Nov-2012  Views: 1885

Get multiple pharma jobs advertisement for November 2012. Government Pharma Jobs, Health Department Pharma Jobs. ...
Pharma Jobs Walk-in on Nov 2012

Pharma Jobs Walk-in on Nov 2012

Walkins | India | Pharma Jobs
Date:
01-Nov-2012  Views: 936

Walk in for Pharma jobs in Dr. Reddy's Laboratories in Nov 2012 | Pharma vacancies in manufacturing, QA, QC in Nov 2012 /Walk-in for M.Pharm,B.Pharm,M ...
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