UAE Pharmacovigilance Associate

1 - 4 years

1 - 4 Lacs

Posted:1 week ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

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We are looking for a highly motivated and detail-oriented Pharmacovigilance to join our growing team in the UAE. The ideal candidate will play a vital role in ensuring the safety and compliance of our pharmaceutical products through effective adverse event reporting and risk management.

Key Responsibilities:

  • Collect, evaluate, and process adverse event reports from various sources (healthcare professionals, patients, regulatory agencies, literature).
  • Perform case triage, data entry, narrative writing, and MedDRA coding.
  • Ensure timely and accurate submission of Individual Case Safety Reports (ICSRs) to regulatory authorities.
  • Assist in preparation of Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and other PV documents.
  • Maintain compliance with global and local regulatory requirements.
  • Participate in signal detection and safety data review.
  • Collaborate with cross-functional teams including clinical, regulatory, and quality departments.
  • Stay updated with the latest regulatory changes in PV (UAE MOHAP, WHO, EMA, FDA guidelines).

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