Job Search

Job for Pharmacovigilance Leader in Novartis

By: Jobs | Views: 300 | Date: 24-Feb-2016

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Pharmacovigilance Leader

Job Description:
Performs pharmacovigilance activities for all assigned Novartis projects or products including identifying and analyzing safety signals based on a comprehensive evaluation of post-marketing data and Serious Adverse Events (SAEs) from clinical trials.
1. Monitors the clinical safety of projects/products and responds appropriately
2. Performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of line listings of single cases, and preparation of investigator notifications. Medical review of single case reports will be performed by associates possessing medical degree.
3. Identifies safety signals based on the review of solicited or unsolicited single cases and confirm that they are not overlooked. Performs signal detection, monitoring and evaluation based on single cases, aggregate data and signal detection tools.
4. Provides input into responses to inquires from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Provides input to responses for legal queries and CPO requests involving safety issues.
5. Provides pharmacovigilance input to initial development of basic prescribing information and is responsible for pharmacovigilance input into updates of this information.
6. Prepares medical input to aggregate clinical safety regulatory reports
7. Provides input to safety profiling and risk management plan
8. Provides guidance as appropriate to Clinical Safety Operations for the coding and causality/expectedness assessment of adverse event reports.
9. Provides expert evaluation on the clinical context of adverse event reports, assessment on the medical conditions, and the implications on Novartis drugs.
10. Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.
11. Participates in review of clinical study protocols/reports/other regulatory documents as needed.
12. Provides relevant input for Global Program/Brand Team (GPT/GBT), Global Clinical Team (GCT), and CTT meetings as needed.
13. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.
- Timeliness and quality of safety analyses, interpretations, and presentations
- Compliance with internal and external regulations and procedures

Candidate profile:
• Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/PhD in relevant field or Medical Degree (MBBS or MD) required Medical degree with specialization preferred. Medical degree is e Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) preferred.

• 3 years clinical experience postdoctoral
• At least 3 years in drug development in a major phar- maceutical company including 2 years in drug safety at an operational or medical position
• Proven ability to analyze, interpret, discuss, and represent safety information both in writing and orally.
• Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information.
• Experience with (safety or others) issue management
• Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications

Additional Information: 
Experience: 2-3 years
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
Job ID: 183487BR
Location: Hyderabad
Last Date: 10th March, 2016

Apply Online:

https://sjobs.brassring.com/TGWEbHost/jobdetails.aspx?jobId=2407666&PartnerId=13617&SiteId=5260

Previous Page Next Page

People Searching On This Page:
  • job doyouknow.in

Related Pages


Opening Jobs For Junior Technician In Biecco Lawrie Limited – Kolkata,Govt. jobs in Kolkata,Govt. jobs in

Opening Jobs For Junior Technician In Biecco Lawrie Limited – Kolkata,Govt. jobs in Kolkata,Govt. jobs in

Openings | India | Government Jobs
Date:
20-Jul-2012  Views: 1818

Opening Jobs For Junior Technician In Biecco Lawrie Limited – Kolkata, Assistance in Supervision / Commissioning / Erection / Testing of MV switchgear ...
Jobs for Content Writer Job opening in Ahmedabad,Vacancy for Jobs for Content Wr

Jobs for Content Writer Job opening in Ahmedabad,Vacancy for Jobs for Content Wr

Openings | Ahmedabad | Journalism Jobs
Date:
07-Mar-2011  Views: 1746

Jobs for Content Writer jobs from Viteb Group, Apply vacancy for Jobs for Content Writer jobs in Editors/Journalism field, with work Experience of 1 ...
Home Based Jobs Job opening in Pune,Vacancy for Home Based Jobs Call Centre/Oper

Home Based Jobs Job opening in Pune,Vacancy for Home Based Jobs Call Centre/Oper

Openings | Pune | BPO Jobs
Date:
15-Feb-2011  Views: 12621

Home Based Jobs jobs from Kavya Consultancy Services, Apply vacancy for Home Based Jobs jobs in Call Centre/Operations field, with work Experience of ...
Jobs for Sales Executive Job opening in Hyderabad,Vacancy for Jobs for Sales Exe

Jobs for Sales Executive Job opening in Hyderabad,Vacancy for Jobs for Sales Exe

Openings | Hyderabad | Sales Jobs
Date:
15-Feb-2011  Views: 1166

Jobs for Sales Executive jobs from Nine Waves, Apply vacancy for Jobs for Sales Executive jobs in Sales/Marketing field, with work Experience of 1 - ...
Jobs for Creative Website Designers Job opening in Ahmedabad,Vacancy for Jobs fo

Jobs for Creative Website Designers Job opening in Ahmedabad,Vacancy for Jobs fo

Openings | Ahmedabad | IT Jobs
Date:
20-Oct-2010  Views: 1107

Jobs for Creative Website Designers jobs from Digital Science Web Technologies Pvt. Ltd., Apply vacancy for Jobs for Creative Website Designers jobs i ...
Post Your Comments (No Login Require)
Name : (required)
Email : (required)
Website :

Comment : (required)

78  + 2 =     
Comments
People Searched About:
Job Doyouknow.In   |  
Google : 9 times | Bing : 1 times |