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.