Date: May 20, 2024
Location: Mumbai, MH, IN, 400083
Company: Apotex
Meta Description: Join Apotex as a Lead Executive in Pharmacovigilance, Mumbai. Oversee safety reports and ensure compliance with global regulations.
About Apotex Inc.
Apotex Inc. is a Canadian-based global health company producing high-quality, affordable medicines. With nearly 7,200 employees worldwide, Apotex operates in manufacturing, R&D, and commercial sectors, delivering medicines to over 75 countries. Learn more at www.apotex.com.
Job Summary
Prepare and review periodic safety update reports (PSURs/PBRERs) in compliance with drug safety regulations and ICH guidelines. Analyze and evaluate adverse reports, resolve causality assessment queries, and participate in global new product development (NPD) and Product Life Cycle Management (PLCM) activities.
Job Responsibilities
Primary Responsibilities:
- Safety Reports: Prepare and peer review PSURs/PBRERs/PADERs for regulatory submission.
- Safety Monitoring: Maintain awareness of safety issues on Apotex products through monitoring and literature review.
- Safety Information: Prepare responses to complex safety queries from internal customers.
- Compliance: Adhere to Global Business Ethics, Quality policies, Safety and Environment policies, and HR policies.
Additional Responsibilities:
- SOP Development: Develop and maintain standard operating procedures (SOPs).
- Training: Develop training documents and track compliance of drug safety reporting.
- System Knowledge: Maintain user-level knowledge of Oracle ARGUS and MedDRA terminology.
- Team Collaboration: Work in a team to achieve outcomes aligned with Apotex values (Collaboration, Courage, Perseverance, Passion).
Supporting Responsibilities:
- Process Improvement: Provide input on process improvement strategies.
- Teamwork: Contribute to a team environment focused on excellent customer service and timely delivery of quality drug safety data.
- External Relationships: Develop strong relationships with external partners and international affiliates.
- Regulatory Interpretation: Interpret PV regulations and apply sound decisions related to guidelines and policies.
- Continuous Learning: Stay current on PV regulations and guidelines.
Job Requirements
| Education | Skills and Abilities | Experience |
|---|---|---|
| Physicians, Pharm.D, M Pharm, Nursing, or related Health Science discipline | Excellent analytical and problem-solving skills Excellent oral and written communication in English Knowledge of MedDRA, Oracle ARGUS, and online literature searching preferred Excellent organizational and interpersonal skills Knowledge of local and international PV regulations and ICH guidelines Advanced knowledge of Microsoft Office (Excel, PowerPoint, Word) | Core PV experience of 3-5 years in the pharmaceutical industry Preferred experience of 1-2 years in periodic reviews on aggregate safety data |
Join Apotex and contribute to global healthcare by ensuring the safety and efficacy of medicines. Apply now to be part of our dynamic team!