Pharmacovigilance Officer

1 day ago

Daman, India BioTalent Search® Full time
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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