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Cliniweb Services
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Pharmacovigilance Associate

Pharmacovigilance Associate

Cliniweb Services

0 years

|

3 - 0 Lacs

Pune, Maharashtra

Posted:2 weeks ago| Platform: SimplyHired logo

Apply

Skills Required

Bachelor's degree In-person Python

Work Mode

On-site

Job Description

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

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