Senior Pharmacovigilance Specialist

Propharma Group India

4 - 6 years

7 - 9 Lacs

Hyderabad Bengaluru

Posted:5 days ago| Platform:

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Skills Required

Pharmacovigilance MedDRA PSUR PV Clinical Operations icsr Pharmacology Clinical Trials MLM Clinical Research clinical safety Medical Writing Drug Safety l2a individual clinical safety report

Work Mode

Hybrid

Job Type

Full Time

Job Description

Job Title

Pharmacovigilance (PV) Specialist

Key Responsibilities

Perform case intake, triage, data entry, quality review, and submission of ICSRs.
Evaluate and code adverse event reports using MedDRA and WHO-DD coding.
Ensure timely reporting of adverse events to regulatory authorities and clients.
Maintain compliance with pharmacovigilance regulations (e.g., FDA, EMA, CDSCO).
Collaborate with cross-functional teams to ensure accurate and complete safety data.
Contribute to audit and inspection readiness.
Prepare periodic safety update reports (PSURs) and other regulatory documents when required.

Qualifications

Bachelors or Masters degree in Pharmacy, Life Sciences, or related field.
Minimum 4 years of hands-on experience in PV ICSR processing.
Strong understanding of global PV regulations and ICH-GCP guidelines.
Familiarity with PV databases (e.g., Argus, ArisG) is an advantage.
Excellent attention to detail and strong analytical skills.
Good communication and documentation skills.

Preferred Attributes

Certification in Pharmacovigilance will be an added advantage.
Ability to work independently and as part of a team.
Willingness to work in shifts if required (based on client/region).

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