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Assistant Manager- Pharmacovigilance, Psrm Pv

1-2 years
Not Disclosed
10 May 10, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Overview: Apotex Inc. is a Canadian-based global health company focused on producing high-quality, affordable medicines for patients worldwide. With nearly 7,200 employees across manufacturing, R&D, and commercial operations, Apotex medicines are accessible in over 75 countries. Through vertical integration, the company specializes in generic, biosimilar, and specialty products.

For more information, visit: www.apotex.com.

Job Summary: As a Medical Reviewer, 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:

  1. Medical review of PADERs and PSURs/PBRERs ensuring compliance with regulations and guidelines.
  2. Maintain awareness of safety issues on Apotex products through ongoing monitoring and literature review.
  3. Prepare responses to complex safety queries from internal customers.

Additional Responsibilities:

  1. Develop and maintain SOPs.
  2. Develop and maintain training documents and track compliance.
  3. Maintain knowledge of Oracle ARGUS and MedDRA terminology.
  4. Contribute to departmental process improvement discussions.
  5. Foster teamwork and excellence in customer service delivery.
  6. Liaise with external partners and international affiliates.
  7. Interpret PV regulations and apply sound decisions related to regulatory guidelines.
  8. Remain current on PV regulations and seek guidance for knowledge enhancement.

Job Requirements: Education: Physicians, Pharm.D, M Pharm, Nursing, or related Health Science discipline.

Knowledge, Skills, and Abilities:

  • 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.

Experience: Safety Physician: Preferred experience of at least 1-2 years in medical review of safety information and aggregate data.

Equal Opportunity Statement: Apotex is committed to fostering an inclusive, accessible work environment where all employees feel valued, respected, and supported. The company offers accommodation for applicants with disabilities as part of its recruitment process. If accommodation is required for an interview or testing, applicants are encouraged to advise Apotex.