Pharmacovigilance Officer

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.