Lead Executive – Pharmacovigilance PV PSRM
Date: May 20, 2024
Location: Mumbai, MH, IN, 400083
Company: Apotex
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
Prepare and review periodic safety update reports (PSURs/PBRERs) in compliance with drug safety regulations and ICH guidelines. Utilize best medical judgment in the analysis and evaluation of adverse reports, promptly resolving causality assessment queries and any other imprecisions in reporting by actively liaising with the reporting sites. Participate in global new product development (NPD) project teams and support Product Life Cycle Management (PLCM) activities.
Job Responsibilities
Primary Responsibilities:
- Prepare and conduct peer review of periodic safety update reports (PSURs/PBRERs/PADERs) for regulatory submission.
- Maintain current awareness of safety issues on Apotex products through ongoing monitoring and literature review, demonstrating scientific skills in the research, analysis, and interpretation of safety data.
- Prepare responses to slightly more complex queries and requests for safety information from internal customers (RA, QA, NPD project teams, etc.).
- Ensure personal adherence to 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:
- Develop and maintain SOPs.
- Develop and maintain training documents and track compliance of internal and external global partners involved in drug safety reporting.
- Maintain user-level knowledge of Oracle ARGUS and MedDRA terminology.
- Work as a member of a team to achieve all outcomes.
- Deliver all work in support of our Values of Collaboration, Courage, Perseverance, and Passion.
- Perform all other duties as assigned.
Supporting Responsibilities:
- Provide input and feedback to departmental process improvement strategy discussions.
- Contribute to the creation and promotion of an environment of teamwork ensuring excellence in customer service through the timely delivery of quality drug safety data.
- Liaise regularly and develop strong working relationships with external partners and international Apotex affiliates, demonstrating corporate values in the performance of work and all interactions.
- Interact with other internal departments when necessary.
- Contribute to the interpretation of PV regulations and apply sound decisions related to regulatory guidelines and policies.
- Show initiative to remain current on new PV regulations and international guidelines, seeking guidance from Group Leader and management to enhance knowledge.
- Perform all work in accordance with established ICH guidelines, regulatory compliance, and safety requirements, maintaining 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.
- Excellent oral and written communication in English.
- Knowledge of MedDRA, Oracle ARGUS, and online literature searching preferred.
- Excellent organizational and interpersonal skills; experience working in a dynamic team environment.
- Excellent knowledge of relevant local and international regulations and ICH guidelines on safety data management in clinical trials and post-approval.
- Advanced knowledge of Microsoft Office: Excel, PowerPoint, Word.
Experience:
- Core PV experience of at least 3-5 years in the pharmaceutical industry.
- Periodic safety and risk management scientist: Preferred experience of at least 1-2 years in periodic reviews on aggregate safety data.