Senior Analyst, GBS-GPV PSRM-GBS-PSRM G

About Apotex Inc.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

For more information visit : www.apotex.com .

Job Summary

Prepares 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 new product development (NPD) project teams and supports Product Life Cycle Management (PLCM) activities.

Job Responsibilities Primary responsibilities

• Prepares 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

Supporting responsibilities

Job Requirements

Education

B Pharm, Pharm.D, M Pharm, Nursing or related Health Science discipline

Knowledge, Skills and Abilities

Excellent analytical and problem-solving skills

Experience

Core PV experience of at least 1-2 years pharmaceutical experience

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Locations - Mumbai, MH, IN, 400079