Pharmacovigilance Officer
16 hours ago
Job Description – Pharmacovigilance Officer
Position:
Pharmacovigilance Officer
Location:
Daman
Experience:
4–5 years
Qualification:
Bachelor's/Master's degree in Pharmacy, Life Sciences, or related field
Certification:
Pharmacovigilance Certification (mandatory)
Job Summary
We are hiring a
Pharmacovigilance Officer
on behalf of our client in the pharmaceutical industry. The role involves end-to-end responsibility for adverse event reporting, signal detection, and regulatory compliance to ensure the highest standards of patient safety and drug safety monitoring.
Key Responsibilities
- Manage collection, evaluation, and reporting of Individual Case Safety Reports (ICSRs).
- Perform medical coding using MedDRA/WHO Drug Dictionary.
- Prepare and review aggregate safety reports (PSURs, PBRERs, DSURs).
- Support signal detection, risk management, and safety data analysis.
- Ensure compliance with international pharmacovigilance regulations (FDA, EMA, CDSCO, ICH).
- Assist in audits, inspections, and quality checks for PV activities.
- Collaborate with global and cross-functional teams to support regulatory submissions.
Key Requirements
- 4–5 years of proven experience in pharmacovigilance/drug safety.
- Pharmacovigilance certification (mandatory).
- Strong knowledge of PV regulations, ICH guidelines, and regulatory reporting systems.
- Hands-on experience with case processing, narrative writing, and aggregate reports.
- Excellent communication, analytical, and documentation skills.
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