Pharmacovigilance Manager
Hyderabad, Telangana, India · Full Time
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- Experience
- 16+ yrs
- Salary
- —
- Openings
- 1
- Posted
- 4 weeks ago
- Work mode
- In office
- Education
- M.B.B.S
- Eligibility
- Candidates holding an M.B.B.S degree in any specialization are eligible to apply.
- Resume
- Required to apply
Where you'll work
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Job description
Overview of Indian Immunologicals Limited
Indian Immunologicals Limited (IIL) operates as a fully owned subsidiary of the National Dairy Development Board (NDDB), a significant autonomous body established in 1983 by an act of Parliament, headquartered in Anand near Baroda, Gujarat. NDDB is recognized as an esteemed national institution aimed at rapid advancement of cooperative movements across dairying, fruit and vegetable processing, dairy machinery, and oil seeds processing sectors.
Educational and Experience Criteria
The ideal candidate must possess an M.B.B.S degree in any specialization and have accumulated more than 16 years of relevant professional experience.
Key Responsibilities
- Serve as Vaccine Safety Physician and act as Deputy Qualified Person Responsible for Pharmacovigilance (QPPV)/Pharmacovigilance Officer in Charge (PvOIC).
- Conduct thorough assessments of reported adverse events, including seriousness, expectedness, and causality.
- Address medical inquiries from consumers and healthcare professionals promptly and accurately.
- Review periodic safety update reports as well as Risk Management Plans.
- Lead clinical investigations related to Serious Adverse Events and prepare comprehensive Individual Case Safety Reports (ICSRs).
- Develop and deliver training modules focused on Pharmacovigilance for staff as needed.
- Evaluate 'Summary of Product Characteristics' (SmPC) and 'Prescribing Information' when launching new products, and monitor for new safety signals on existing products.
- In clinical trials, manage preparation of Investigator’s Brochures and Safety Reporting Plans, review protocols, notify regulatory authorities, and assess serious adverse events, ensuring timely ICSR preparation and submission.
- Function as QPPV/PvOIC during their absence and act as Biosafety Officer.
Authorities and Reporting Relationships
- Act as Deputy QPPV/PvOIC with authorized responsibilities when the primary designated persons are unavailable.
- Report to the Chief Manager, Medical Services.
Minimum education
Bachelor's Degree
Industry
Hospitals & Health Care