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: .
Job Summary
Global Pharmacovigilance (GPV) is an operating department within Global Quality & Compliance of Apotex. The GPV department is involved in the processing and submission of adverse drug reaction reports production of periodic safety reports, signal detection and risk management to support the development and commercialisation of Apotex products in the markets in which we do business, in compliance with pharmacovigilance (PV) regulations & relevant ICH guidelines.
Performs oversight quality check activities of global pharmacovigilance processes including but not limited to: ICSR review and processing; regulatory reporting; case document management; literature reviews. Occasionally helps with reviews of Individual case safety reports (ICSR) and submissions to regulatory authorities, as needed. Interacts with internal (Global Business Services, Regulatory Affairs, Apotex Affiliates) and external customers (vendors) in relation to Pharmacovigilance process compliance.
Job Responsibilities
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