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Associate, Global Pharmacovigilance (Contract)
Apotex - Greater Toronto Area, ON

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Org. Unit Descriptor:
Global Pharmacovigilance (PV) is an operating department within the AGO-Scientific and Regulatory Affairs. The PV department is involved in the processing and submission of adverse drug reaction reports and safety data management to support the development and commercialization of Apotex products in the markets in which we do business, in compliance with PV regulations & relevant ICH guidelines.
Job Summary: Performs global Pharmacovigilance processes of the unit: Quality Management Review and compliance tracking; Clinical trial serious adverse event (SAE) reconciliation and occasional case processing; Spontaneous adverse drug reaction reporting and case processing; literature review; drafting Periodic Safety Update report; Risk Management plans on products developed and manufactured by Apotex and Risk Management program support. Interacts with health professionals and consumers and affiliate offices during investigation of all case reports. Prepares and submits expedited case reports and periodic safety update (PSUR) reports in compliance with drug safety regulations and ICH Guidelines. Participates in global new product development (NPD) project teams and supports Product Life Cycle Management (PLCM) activities relating to Risk Management programs and pharmacovigilance. Provides after-hour coverage of PV responsibilities as required.

Job Responsibilities:
Relationship with Internal/External Customers & Stakeholders:
Decision Making:
Leadership/Professional Development of Self & Others:
Compliance and Due Diligence:
Job Requirements:
B.Sc, MSc. In related Health Science discipline

Apotex - 3 years ago

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