Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com.
Job Summary
Prepares/ reviews periodic safety update reports (PSURs/ PBRERs) in compliance with drug safety regulations and ICH Guideline. Utilizes best medical judgement 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. Participates in global recent 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.
• Maintains current awareness of safety issues on Apotex products through ongoing monitoring & literature review demonstrating scientific skills in the research, analysis and interpretation of safety data.
• Prepares responses to slightly more complex queries, and requests for safety information from internal customer (RA, QA, NPD project teams etc.).
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
Additional responsibilities
• Develops and maintains SOPs.
• Develops and maintains training documents and tracks compliance of internal and external global partner
📌 Lead Exec, GBS-GMA-GPV PSRM-GBS-PSRM G (Mumbai)
🏢 Apotex
📍 Mumbai
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