Pharmacovigilance Officer

2 hours ago


Daman, India BioTalent Search® Full time

Job Description – Pharmacovigilance OfficerPosition: Pharmacovigilance OfficerLocation: DamanExperience: 4–5 yearsQualification: Bachelor’s/Master’s degree in Pharmacy, Life Sciences, or related fieldCertification: Pharmacovigilance Certification (mandatory)Job SummaryWe 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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