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Application and Database Specialist

4 weeks ago

Québec QC, Canada Brunel Full time

Pharmacovigilance Specialist (renewable contract) Remote – Quebec or Ontario

We are hiring a Pharmacovigilance Specialist for one of our pharmaceutical clients based in either Ontario or Quebec. The Pharmacovigilance Specialist is responsible for maintaining an efficient vigilance system in compliance with the Health Canada regulations and guidelines; participating in other Pharmacovigilance processes (e.g., postmarket surveillance activities / training); ensuring appropriate contacts with Regulatory Affairs, Quality Assurance, Medical Affairs, and Global Pharmacovigilance.

Analyze and process adverse events and safety reports with utmost quality and timeliness in accordance with Global and Local Pharmacovigilance procedures.
Collect, pursue follow-up information to complete quality adverse event reports and transmit all local adverse events to Global Pharmacovigilance.
Evaluate domestic and foreign ICSRs (marketed and non-marketed drugs) for submission to Health Canada according to Canadian regulations and within prescribed timelines.
Respond to queries and requests from Global Pharmacovigilance.
Organize and ensure maintenance of the electronic filing and archiving system according to corporate and Canadian requirements.
Document and update case information into the global safety database.
Collaborate in developing and maintaining the local Pharmacovigilance SOPs and procedures.
Update the list of all Canadian drug licensing status and renewals, in conjunction with Regulatory Affairs.
Participate in training of PV Associate on their assigned activities.
Support associate with inbound and outbound case management activities as needed and as per corporate and local requirements and timelines.
Maintain current knowledge of all relevant local Pharmacovigilance regulations in regard to drug, natural health and cosmetics products.
Coordinate responses to questions and requests from Regulatory Authorities.

Bilingual French/English with great verbal and written communication.
~ Degree within healthcare (Pharmacy or Medical Degree: B. Advanced software user
~3-years’ experience in a relevant Pharmacovigilance setting in the pharmaceutical industry. Able to manage projects
~ Skilled with computer applications
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