APOTEX HIRING IN PHARMACOVIGILANCE
Position: 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 worldwide. Apotex employs nearly 7,200 people globally, with medicines accessible in over 75 countries. The company focuses on developing and selling generic, biosimilar, and specialty products. For more information, visit www.apotex.com.
Job Summary:
Prepare and review periodic safety update reports (PSURs/PBRERs) following drug safety regulations and ICH guidelines. Analyze and evaluate adverse reports, resolve causality assessment queries, and liaise with 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 reviews of PSURs/PBRERs/PADERs for regulatory submission.
- Monitor safety issues on Apotex products through literature reviews and data analysis.
- Respond to complex safety information queries from internal customers.
- Ensure adherence to compliance programs, including Global Business Ethics, Global Quality policies, Safety and Environment policies, and HR policies.
Additional Responsibilities:
- Develop and maintain SOPs and training documents.
- Track compliance of internal and external global partners in drug safety reporting.
- Maintain user-level knowledge of Oracle ARGUS and MedDRA terminology.
- Collaborate with team members to achieve outcomes.
- Deliver work in line with Apotex Values: Collaboration, Courage, Perseverance, and Passion.
- Perform other duties as assigned.
Supporting Responsibilities:
- Provide feedback for departmental process improvements.
- Foster teamwork and ensure timely delivery of quality drug safety data.
- Develop strong working relationships with external partners and international affiliates.
- Interact with other internal departments as necessary.
- Interpret PV regulations and apply decisions related to regulatory guidelines and policies.
- Stay current on new PV regulations and international guidelines.
- Perform work according to ICH guidelines, regulatory compliance, and safety requirements.
Job Requirements:
Education:
- Physicians, Pharm.D, M Pharm, Nursing, or related Health Science discipline.
Knowledge, Skills, and Abilities:
- Excellent analytical and problem-solving skills.
- Proficiency in English, both oral and written.
- Preferred knowledge of MedDRA, Oracle ARGUS, and online literature searching.
- Strong organizational and interpersonal skills.
- Understanding of local and international regulations and ICH guidelines on safety data management.
- Advanced knowledge of Microsoft Office: Excel, PowerPoint, Word.
Experience:
| Role | Experience Required |
|---|---|
| Core PV | 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 |
Meta Description:
Join Apotex as a Lead Executive in Pharmacovigilance in Mumbai. Enhance your PV skills with a global health leader.