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:

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.

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Assistant Manager- Pharmacovigilance, PSRM PV