Pharmacovigilance Specialist

1 week ago

Mumbai, Maharashtra, India beBeeMedical Full time ₹ 1,50,000 - ₹ 28,00,000
About Our Team

We are seeking a highly skilled and motivated Medical Review Specialist to join our team. As a Medical Review Specialist, 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.

Your role involves utilizing medical judgment to analyze adverse reports, resolving queries, and supporting global new product development (NPD) project teams and Product Life Cycle Management (PLCM) activities.

Primary Responsibilities:
  • Medical review of PADERs and PSURs/PBRERs ensuring compliance with regulations and guidelines.
  • Maintain awareness of safety issues on products through ongoing monitoring and literature review.
  • 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.
  • Maintain knowledge of Oracle ARGUS and MedDRA terminology.
  • Contribute to 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.
  • Remain current on PV regulations and seek guidance for knowledge enhancement.
Requirements

We are looking for candidates with a strong educational background in Health Science disciplines, including Physicians, Pharm.D, M Pharm, Nursing, or related fields.

Skills and Qualifications:
  • Excellent analytical and problem-solving skills.
  • Excellent oral/written communication skills in English.
  • Knowledge of MedDRA, Oracle ARGUS, and online literature searching is 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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