Assistant Manager- Pharmacovigilance, PSRM PV

• 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:

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

Additional Responsibilities:

• Develop and maintain SOPs.
• Develop and maintain training documents and track compliance.
• Maintain knowledge of 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.
• 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.