Pharmacovigilance officer

23 hours 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 Med DRA/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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