Team Lead - Pharmacovigilance, Associates & Coordinators

Team Lead – Pharmacovigilance, Associates & Coordinators

Remote in Canada

Introduction

We are currently hiring a Team Lead – Pharmacovigilance Associates & Coordinators for our client based in Canada. As a Team Lead, you will play a crucial role in ensuring the smooth operation of our Pharmacovigilance activities while maintaining compliance with corporate and Canadian regulatory reporting requirements. You will be responsible for training, supervising, and coaching a team of Pharmacovigilance Coordinators and Associates, optimizing procedures, and managing workload distribution. This remote position offers the flexibility to work from anywhere in Canada.

Responsibilities

• Train, supervise, and coach Pharmacovigilance Coordinators and Associates on their assigned activities
• Ensure the smooth operation of Coordinator and Associate case management activities to maintain compliance with corporate and Canadian regulatory reporting requirements
• Review and document monthly reports for metrics on PV-related activities, analyze and communicate trends
• Participate in the maintenance of the PV paper and electronic filing and archiving system according to corporate and Canadian requirements
• Ensure timely submission of ICSRs for marketed products and medical devices subject to expedited reporting according to Canadian regulations
• Monitor and support the preparation of written follow-up requests to meet prescribed timelines
• Collaborate in developing and maintaining local Pharmacovigilance standard operating procedures (SOPs), work instruction, and job aids
• Respond to queries and requests from internal and external stakeholders
• Support activities involving product launch, studies, and product alerts
• Support in the configuration and maintenance of the PV product list
• Provide support for the compliance monitoring of Individual Case Safety Reports (ICSRs) and generate metrics on case handling
• Ensure the quality of the PV teams and the work of the global PV vendors, addressing any issues in a timely fashion
• Participate in audit and inspection readiness
• Monitor Coordinator and Associate workload and oversee assignment of tasks to ensure compliance with corporate and Canadian requirements
• Manage electronic case submission issues with Health Canada in collaboration with the company's global PV team, including transmission failures and database configuration problems
• Support reconciliations of the company's third-party vendor programs and licensed partners as per corporate requirements and monitor key performance indicators
• Provide overall support to the PV team activities
• Participate in the ongoing optimization of PV procedures as well as inter-departmental procedures affecting PV
• Participate in PV training attestations for external vendors
• Assess needs, optimize, and ensure maintenance of the PV Coordinators and Associates procedures according to corporate and Canadian requirements

Requirements

• Experience in managing and leading teams is an asset
• Bachelor’s degree in life sciences, HCP degree preferred, or equivalent experience
• Strong working knowledge of FDA, Health Canada, and/or EMA regulations/guidance/guidelines regarding clinical safety/Pharmacovigilance
• Must be bilingual in French and English
• Proficiency with Microsoft Word, Excel, PowerPoint, SharePoint, and Adobe Acrobat
• 2-6 years of experience in Pharmacovigilance at a pharmaceutical company, biotech, or CRO

What We Offer

Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We’ll get you going while you get on with the job.

About Us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.