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 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.

- 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.

Additional responsibilities

- Develops and maintains SOPs.

- Develops and maintains training documents and tracks compliance of internal and external global partners involved in drug safety reporting.

- Maintains user-level knowledge of Oracle ARGUS and MedDRA terminology.

- Works as a member of a team to achieve all outcomes.

- Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion.

- All other duties as assigned.

Supporting responsibilities

- May provide input and feedback to departmental process improvement strategy discussions.

- Contributes to the creation and promotion of an environment of teamwork ensuring excellence in customer service through the timely delivery of quality drug safety data.





- Liaises regularly and develops robust working relationship with external partners and international Apotex affiliates and demonstrates corporate values in the performance of work and in all interactions with others.

- Interacts with other internal departments when necessary.

- Contributes to interpretation of PV regulations and applies sound decisions related to regulatory guidelines and policies.

- Shows initiative to remain current on new PV regulations and international guidelines and seeks guidance from Group Leader and management to enhance knowledge.

- Performs all work in accordance with all established ICH guidelines, regulatory compliance and safety requirements and maintains current knowledge on all relevant Pharmacovigilance regulations.

Job Requirements

- Education: Physicians, Pharm.D, M Pharm, Nursing or related Health Science discipline

- Knowledge, Skills and Abilities: Excellent analytical and problem-solving skills

- Knowledge, Skills and Abilities: Excellent oral/written communication in English

- Knowledge, Skills and Abilities: Knowledge of MedDRA, Oracle ARGUS online literature searching preferred

- Knowledge, Skills and Abilities: Excellent organizational interpersonal skills;

experience in working in a dynamic team environment

- Knowledge, Skills and Abilities:



Excellent knowledge of relevant local and international regulations and ICH guidelines on safety data management in clinical trials and post-approval

- Knowledge, Skills and Abilities: Advanced knowledge of Microsoft Office: Excel, PowerPoint, Word

- Experience: Core PV experience of at least 3-5 years pharmaceutical experience

- Experience: Periodic safety and risk management scientist: Preferred experience of at least 1-2 years on periodic reviews on aggregate safety data

At Apotex, we are committed to fostering a welcoming and accessible work environment, where everyone feels valued, respected, and supported to succeed.

We offer 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

Role: Pharmaceutical &

- Biotechnology - Other,

Industry Type: Pharmaceutical &

- Life Sciences,

Department: Research &

- Development,

Employment Type: Full Time, Permanent

Role Category: Pharmaceutical &

- Biotechnology

Education

UG: Any Graduate

PG: Any Postgraduate

Key Skills pharmaceuticaldata managementnpdoraclehr policiescustomer servicedrug safetyliterature reviewnew product developmentmicrosoft officeliteraturecompliancecomplex queriesargusmeddraclinical trialsacquisitions

📌 Lead Exec, GBS-GMA-GPV PSRM-GBS-PSRM G (Mumbai)
🏢 Apotex
📍 Mumbai