Performs and provides peer review for the global pharmacovigilance processes: Signal detection, Risk management plans on products developed and manufactured by Company. Interacts on a peer level with internal customers (Company affiliates) and external customers (health professionals, consumers) during investigation of all case reports. Utilizes best medical judgment in the analysis and evaluation of adverse reports, promptly resolving causality assessment queries and any other impreciseness in reporting by actively liaising with the reporting sites. Prepares/ reviews periodic safety update reports (PSURs/ PBRERs) in compliance with drug safety regulations and ICH Guideline. Participates in global new product development (NPD) project teams and supports Product Life Cycle Management (PLCM) activities.

Job Responsibilities:

Primary responsibilities :

- Prepares and conducts peer review of periodic safety update reports (PSURs/PBRERs/PADERs) for regulatory submission.

- Performs Signal detection/management activities in accordance with internal procedures and regulatory guidelines/requirements.

- Conducts literature reviews and provides assessment and analysis of published literature.

- Maintains current awareness of safety issues on Company products through ongoing monitoring & literature review demonstrating scientific skills in the research, analysis and interpretation of safety data.

- Assists in the preparation/review of Risk Management plans.

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