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Dr. Reddy's Opening for Pharmacovigilance Lead - India & RoW

By: Jobs Search | Views: 1125 | Date: 11-Dec-2012

Job detail for the post of Pharmacovigilance Lead - India & RoW @ Dr. Reddy's in Dr. Reddy's Laboratories Ltd. Hyderabad / Secunderabad, 8 to 12 years of experience. Hiring for Pharmacovigilance Lead - India & RoW @ Dr. Reddy's in Hyderabad / Secunderabad for Exp. 8-12 yrs.

Job Description:

Objective:

Manage and Develop Pharmacovigilance system of India and ROW countries. Within: Regulations of India and ROW, ICH, agreed policies and procedures of DRL. With the objective of: Providing pharmacovigilance service that meet regulatory and legal obligations

Team Members: 2

Dr.Reddys' Logo

Education & Experience: MD with 8-10 years of experience in Pharmacovigilance

Business Understanding: Good understanding of principles of pharmacoviglance, pharmaceutical industry including the role of generic sectors in different India, ROW countires, Europe, US and project management.

Responsibilities:

Meeting India/RoW pharmocovigilance regulatory requirements

1) Review and conduct medical assessments

1a) of spontaneous ICSR's and,

1b) ICSRs from BA/BE studies,

1c) Clinical trials

2) Monitor adverse events through the reporter and report to:

2a) DCGI

2b) Local country representative/PV coordinator (RoW),

3) Conduct medical review of PSURs and submit within timelines to:

3a) DCGI

3b) RA

IN ORDER TO comply with DCGI Pharmacovigilance requirements

Develop pharmacovigilance system and processes

1) Identify pharmacovigilance processes and procedures:

1a) Create and review SOP's and related documents with respect to local regulatory requirements,

1b) Prepare and review safety data exchange agreements (SDEA) with licensing partners,

1c) Review of safety section of protocols

1d) Prepare CCSI for the products and oversee quality requirements related to drug safety activities IN ORDER TO establish pharmacovigilance quality management system and achieve compliance.

Query resolution (Regulatory agencies and licensing partners)

Respond to queries and requests related to safety of products and the pharmacovigilance system at Dr Reddys from India and ROW IN ORDER TO meet the regulatory compliance requirements

Participate in regulatory inspections

Explain the PV systems and procedures to regulatory agencies during inspections IN ORDER TO effectively participate in the regulatory inspection

Monitoring Risk-benefit Analysis Global

Conduct risk benefit analysis for PSURs, identify safety signals, conduct detailed evaluation of risks, schedule review of existing products and recommend corrective actions like re-labeling, addition of warnings, product recalls IN ORDER to ensure patient safety

People management

Validate ARIS G database(during upgradation), work flow design , set up validations, provide inputs to PV support team on functional requirements, liaison with IS (Information System)in procurement of licenses MedDRA,WHO DDE and interact with global PV team as and when required IN ORDER TO establish a robust IT system for Pharmacovigilance

Creation of Hazard Assessment Reports

Support QA team as and when required in relation to drug safety, conduct health hazard safety assessment as directed by quality team whenever required to assess the safety of components of the formulation IN ORDER TO document the potential risk associated with drug

Salary:

Not Disclosed by Recruiter

Functional Area:

Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:

Medical Professional

Role:

Pharmacist/ Chemist/ Bio Chemist

Keyskills:

pharmacovigilance, pharmacology, clinical, medical

Desired Candidate Profile:

Education:

(UG - MBBS - Medicine) AND (PG - M.S/M.D - Any Specialization) AND ( Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required)

Company Profile:

Dr. Reddy's Laboratories Ltd.
http://www.drreddys.com
We are a global pharmaceutical company committed to providing affordable and innovative medicines for healthier lives through our three core businesses: Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products.

Contact Details:

Recruiter Name:

Venkat Vishwanath

Contact Company:

Dr Reddys Laboratories Ltd

Email Address:

Reference Id:

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