Safety Specialist

3 days ago

Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878
Pharmacovigilance Manager

We are seeking a highly skilled Pharmacovigilance Manager to join our team. In this role, you will be responsible for reviewing Periodic Adverse Drug Experience Reports (PADERs) and periodic safety update reports (PSURs/PBRERs) in compliance with drug safety regulations and ICH guidelines.

Key Responsibilities:

  • Review PADERs and PSURs/PBRERs ensuring compliance with regulations and guidelines.
  • Monitor and review literature to maintain awareness of safety issues on Apotex products.
  • Prepare responses to complex safety queries from internal customers.

Additional Responsibilities:

  • Develop and maintain Standard Operating Procedures (SOPs).
  • Develop and maintain training documents and track compliance.
  • Stay up-to-date with Oracle ARGUS and MedDRA terminology.
  • Contribute to departmental process improvement discussions.
  • Foster teamwork and excellence in customer service delivery.
  • Liaise with external partners and international affiliates.
  • Interpret PV regulations and apply sound decisions related to regulatory guidelines.

Requirements:

  • Physicians, Pharm.D, M Pharm, Nursing, or related Health Science discipline.
  • Excellent analytical and problem-solving skills.
  • Excellent oral/written communication in English.
  • Knowledge of MedDRA, Oracle ARGUS, and online literature searching preferred.
  • Excellent organizational and interpersonal skills.
  • Advanced knowledge of relevant local and international regulations and ICH guidelines.
  • Advanced knowledge of Microsoft Office: Excel, PowerPoint, Word.

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