Assistant Manager- Pharmacovigilance, PSRM PV

3 weeks ago


Mumbai, Maharashtra, India Thepharmadaily Full time
Job Description

- 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.

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