Apotex Inc., a Canadian-based global health company, stands at the forefront of providing high-quality, affordable medicines to patients worldwide. With a strong presence in over 75 countries, the company employs nearly 7,200 professionals across manufacturing, R&D, and commercial operations. Apotex focuses on generic, biosimilar, and specialty product development, ensuring accessibility and affordability in healthcare.
Key Responsibilities of the Role
As an Executive in the Global Pharmacovigilance and Patient Safety Risk Management (GBS-GPV-PSRM) team, you will play a pivotal role in ensuring drug safety and regulatory compliance. Here are the core and supporting responsibilities:
Primary Responsibilities:
- Prepare periodic safety update reports (PSURs, PBRERs, PADERs) for regulatory submissions.
- Conduct thorough safety monitoring through literature reviews and adverse report analyses.
- Address complex queries and safety information requests from internal stakeholders.
- Ensure adherence to compliance programs, including global quality and safety policies.
Additional Responsibilities:
- Develop and maintain Standard Operating Procedures (SOPs) and training documents.
- Track compliance of internal and external partners in drug safety reporting.
- Maintain user-level expertise in Oracle ARGUS and MedDRA terminology.
- Collaborate with cross-functional teams to ensure the delivery of high-quality drug safety data.
Supporting Responsibilities:
- Contribute to process improvement strategies and teamwork-focused initiatives.
- Liaise with international affiliates and external partners to build robust relationships.
- Stay updated on evolving pharmacovigilance regulations and international guidelines.
Required Qualifications
Education:
- A degree in Medicine (Physician), Pharm.D, M.Pharm, Nursing, or a related Health Science discipline.
Skills and Knowledge:
- Strong analytical and problem-solving skills.
- Excellent communication (written and oral) in English.
- Knowledge of MedDRA, Oracle ARGUS, and online literature research preferred.
- Advanced proficiency in Microsoft Office (Excel, PowerPoint, Word).
- Familiarity with ICH guidelines and pharmacovigilance regulations for clinical trials and post-approval processes.
Experience:
- A minimum of 2-3 years of core pharmacovigilance experience in the pharmaceutical industry.
- Preferred 1-2 years of experience in periodic reviews and aggregate safety data management.
