Pharmacovigilance Offres d'emploi - Ancienne lorette qc

Pharmacovigilance Specialist (renewable contract)

Remote – Quebec or Ontario

Introduction

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.

Responsibilities

• 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.
• Submit the Canadian reportable adverse reactions to Health Canada according to their regulations and guidance’s.
• Respond to queries and requests from Global Pharmacovigilance.
• Run monthly submissions compliance report and communicate with team members.
• 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.
• Interact with other functional areas / departments to process adverse events efficiently & reliably.
• 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.
• Provide overall support to the PV on all team activities.
• 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.

Requirements

What We Offer

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About Us

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