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Pharmacovigilance Associate

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Pune Maharashtra, India Cliniweb Services Full time

Collect, review, and process adverse event reports from clinical trials, post-marketing sources, and literature.
- Ensure timely and accurate entry of safety data into safety databases (e.g., Argus, ARISg).
- Prepare and submit Individual Case Safety Reports (ICSRs) to regulatory authorities within stipulated timelines.
- Conduct follow-ups with healthcare providers or patients for missing information.
- Assist in the preparation of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
- Monitor global pharmacovigilance regulatory requirements and ensure compliance.
- Collaborate with cross-functional teams such as Regulatory Affairs, Medical Affairs, and Clinical Operations.
- Participate in signal detection and safety data review activities.

**Job Types**: Permanent, Fresher

Pay: ₹356,822.62 - ₹601,606.13 per year

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift

Work Location: In person