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Pharmacovigilance Officer

Pharmacovigilance Officer

BioTalent Search®

5 years

0 Lacs

daman daman and diu india

Posted:1 month ago| Platform:

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Skills Required

pharmacovigilance certification reporting signal compliance evaluation reports coding support risk management data regulations audits checks processing writing communication documentation

Work Mode

On-site

Job Type

Full Time

Job Description

Position:

Location:

Experience:

Qualification:

Certification:

Job Summary

Pharmacovigilance Officer

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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Pharmacovigilance Officer