St-coordinator, Pharmacovigilance - North York, Canada - Apotex Inc.
Description
About Apotex Inc.
Job Summary:
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.
Responsibilities:
- 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.
Job Requirements:
- Education
- Knowledge, Skills and Abilities
- oStudy focus on health science /biotechnology or equivalent
- oStrong oral and written communication skill
- oDetail oriented with good analytical skills
- oStrong organizational & interpersonal skills
- oAbility to work on multiple tasks with changing priorities.
- oExcellent working knowledge of Word, Excel and Power Point are essential.
- oKnowledge 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.
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