Pharmacovigilance Scientist
Location: Chandigarh
Position Code: PVS001
Job Type: Full-Time
Job Description:
We are hiring a Pharmacovigilance Scientist to manage all activities related to adverse event (AE) and serious adverse event (SAE) processing, follow-up, analysis, and regulatory reporting for both human and veterinary products — marketed and investigational. This role involves working within global regulatory requirements and client specifications to ensure the highest quality and compliance.
Key Responsibilities:
Process, analyze, and report individual case safety reports (ICSRs) for AEs and SAEs in accordance with regulatory timelines
Perform regulatory reporting of safety data for both investigational and marketed products
Prepare aggregate safety reports such as:
PBRERs / PSURs
Addendum to Clinical Overviews (ACOs)
Addendum PSURs / PSUR Line Listings
US PADERs
Conduct quality checks of aggregate safety reports before submission
Support signal detection and issue/event analyses through cumulative safety data review
Liaise with global teams and ensure timely and accurate data entry into safety databases
Contribute to process improvement initiatives in pharmacovigilance practices
Qualifications:
Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, or Biophysics)
OR
BDS (Dentistry), B.V.Sc., or M.V.Sc. in Veterinary Sciences
Experience in pharmacovigilance is a strong advantage
Skills & Competencies:
Good understanding of medical terminology and clinical concepts
Proficient in written and spoken English
Excellent communication and report writing skills
Strong analytical ability with capacity to interpret safety data independently
Skilled in Microsoft Office (Word, Excel, PowerPoint) and Windows-based applications
Experience with pharmacovigilance databases and web-based tools is preferred
Ability to synthesize medical literature and draft unambiguous scientific summaries
Capable of prioritizing and managing multiple safety deliverables with precision
Estimated Salary: ₹4.5 – ₹7.5 LPA (based on experience and qualifications)
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