About Apotex Inc.
Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.
The Global Pharmacovigilance department is responsible for the monitoring of the safety of Apotex globally registered products. Global Pharmacovigilance Co-op will support the safety operations function within Global Pharmacovigilance Department and will be responsible for:
Assisting with safety operational oversight activities related to case processing including compliance monitoring and reconciliation.
Assisting with Global Safety Database administrative activities including upgrade validation testing. Cross-training opportunities on Apotex ARGUS global safety database.
- Gather, evaluate, organize and analyze information pertinent to regulatory and internal compliance metrics and present variance analysis.
- Undertake Global Safety Database validation testing activities with respect to upgrade activities under supervision of Manager, Safety Database Operations.
- Assists with reconciliation activities
- Perform all work in accordance with established regulatory, compliance and safety requirements.
- Work as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.
Enrolled in a University Program
Demonstrated Pharmaceutical or pharmacovigilance interest is an asset
Study focus on health science /biotechnology or equivalent
Strong oral and written communication skill
Detail oriented with good analytical skills
Strong organizational & interpersonal skills
Ability to work on multiple tasks with changing priorities.
Excellent working knowledge of Word, Excel and Power Point are essential.
Knowledge of basic Healthcare regulatory requirements would be helpful.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.