Apotex Inc., headquartered in Canada, is a leading global health company committed to providing high-quality, affordable medicines. With nearly 7,200 employees worldwide, Apotex operates across manufacturing, R&D, and commercial sectors, distributing its products to over 75 countries.
Role Summary: The Lead Executive in Global Pharmacovigilance (PV) will play a key role in processing, quality reviewing, and submitting individual case safety reports (ICSRs) to regulatory authorities and business partners. This position ensures compliance with Apotex’s PV practices and global regulations, supporting the safe and effective use of Apotex products.
Key Responsibilities:
- Conduct precise data and quality reviews of ICSRs to ensure adherence to company conventions, including narrative compilation, MedDRA coding, and causality assessments.
- Review processed ICSRs for compliance with SOPs, including follow-up reviews.
- Identify and address data quality issues and non-compliance with SOPs in collaboration with service providers.
- Perform expectedness assessments and confirm ICSR reportability based on regulatory submission rules.
- Submit ICSRs to regulatory authorities, Apotex affiliates, and business partners following departmental guidelines.
- Respond promptly to ICSR-related queries from stakeholders.
- Maintain document management, including scanning and filing, per SOPs.
- Contribute to the oversight of PV processes, service providers, and partnerships.
- Maintain knowledge of ARGUS, MedDRA, and relevant PV tools.
- Ensure timely completion of CAPA effectiveness for audit and inspection-related corrective actions and discuss outcomes with leads.
- Process customer complaints and quality complaint reports per procedural documents.
Supporting Responsibilities:
- Collaborate and work safely to achieve team goals.
- Uphold Apotex’s values and adhere to compliance programs, quality policies, and safety regulations.
- Perform additional relevant duties as assigned.
Qualifications:
- Education: Pharm.D., M.Pharm, Nursing, or related Health Science degree.
- Skills:
- Strong oral and written communication.
- Preferred knowledge of MedDRA, ARGUS, and literature review.
- Proficiency in Microsoft Office (Excel, PowerPoint, Word).
- Strong organizational and interpersonal abilities.
- Familiarity with local and international PV regulations and ICH guidelines.
- Experience:
- Minimum of 2-3 years in pharmacovigilance.
- Preferred 1-2 years of experience in quality review and ICSR submissions.
