Pharmacovigilance Associate

Pharmacovigilance Associate (renewable contract)

Remote – Ontario or Quebec

Introduction

We are hiring a Pharmacovigilance Associate for one of our pharmaceutical clients. The Pharmacovigilance Associate will support coordinators with case management activities as needed and as per corporate and local requirements and timelines. This is a renewable contract position, where the successful candidate will work fully remotely in Ontario or Quebec.

Responsibilities

• Data Entry of Individual Case Safety Reports (ICSRs) to the pharmacovigilance (PV) safety databases as per corporate and local requirements and timelines.
• Ensure that ICSRs for marketed products and medical devices subject to expedited reporting according to Canadian regulations are submitted to Health Canada within prescribed timelines.
• Monitor and support the preparation of written follow up requests to ensure timelines prescribed by local/global and corporate requirements are met.
• Perform reconciliations of the company‘s third party vendors programs, licensed partners as well as inter-departmental teams, as per corporate requirements and monitor key performance indicators.
• Provide support for the compliance monitoring of Individual Case Safety Reports (ICSRs) and generating metrics on case handling.
• Manage the external vendor training records including the launching of annual refresher training.
• Process Canada Vigilance queries and Access to Information requests/results.
• Support the analysis of reports in PV databases.
• Respond to queries and requests from internal and external stakeholders.
• Support the company‘s Project Leaders in compiling information for the LPSMF on a regular basis.
• Collaborate in developing and maintaining the local Pharmacovigilance standard operating procedures (SOPs), working instructions and job aids.
• Participate in the maintenance of the PV paper and electronic filing and archiving system according to corporate and Canadian requirements.
• Participate in the ongoing optimization of PV procedures as well as inter-departmental procedures affecting PV.
• Provide overall support to PV team activities.

Requirements

• Bachelor’s degree in life sciences
• 2 – 6 years experience in Pharmacovigilance at a pharmaceutical company, biotech, or CRO.
• Strong working knowledge of FDA, Health Canada and/or EMA regulations/guidance/guidelines with respect to clinical safety / Pharmacovigilance.
• Proficient with Microsoft Word, Excel, PowerPoint, SharePoint, and Adobe Acrobat
• Must be bilingual French/English.

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About Us

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