Pharmacovigilance Manager

PUB316553

About this role

About this role

Introduction

We’re hiring a Pharmacovigilance Manager with our client, a global pharmaceutical company, to join their team. This is a long-term contract and home-based opportunity for now, however it will be required to go to the office some days a week.

This professional will be responsible for the oversight of Brunel staffs local PV activities in this client.

Responsibilities

  • Ensure smooth operation of case management activities to maintain compliance with corporate and Canadian regulatory reporting requirements.
  • Assess needs, optimize, and ensure maintenance of the PV procedures according to corporate and Canadian requirements.
  • Monitor workload and oversee assignment of tasks to ensure compliance with corporate and Canadian requirements.
  • Compile case management metrics on a monthly basis and analyze/communicate any trends.
  • Train, supervise and coach PV Coordinators on their assigned activities.
  • Support Coordinators with inbound and outbound case management activities as needed and as per corporate and local requirements and timelines.
  • Assess needs, organize and ensure maintenance of the electronic filing and archiving system according to corporate and Canadian requirements.
  • Evaluate domestic and foreign ICSRs (marketed and non-marketed drugs) for submission to Health Canada according to Canadian regulations and within prescribed timelines. Contribute to the development and organization of a local quality system (SOPs) supporting all Pharmacovigilance activities.
  • Review and Communication of new global quality documents supporting all Pharmacovigilance activities.
  • Monitor and manage the CPOC workload, budget including quarterly meetings with Parexel.
  • Ensure the quality of the CPOC work and address any issues in a timely fashion.
  • Contribute to the management of vendor PV agreements including monitoring of key performance indicators.
  • Contribute to the management of safety data exchange agreements with license partners, including performing regular reconciliations.
  • Manage the PV team's training records and ensure inspection readiness.
  • Manage the external vendor training records including the launching of annual refresher training.
  • Participate in the ongoing optimization of PV procedures as well as inter-departmental procedures affecting PV.
  • Provide overall support to the PV on all team activities.

Requirements

Requirements

Requirements

  • 4 to 7 years of Pharmacovigilance or Drug safety experience
  • Bachelor’s degree in science or Pharma
  • Previous experience managing or mentoring a team.
  • Good communication and analytical skills
  • English and French required.

Benefits

Benefits

Why work through Brunel? We start with competitive rates, a comprehensive benefits package and a safe on-boarding process. With our industry insights and recruiter expertise, we are supporting projects and clients worldwide. With Brunel you gain experience and expertise, building on your skills and developing your career further.

Join the Brunel Family

Career interview session

Join the Brunel Family

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. Join us today

Start applying immediately

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume or up-to-date LinkedIn / Xing profile
Apply now

Any questions remaining?

Your consultant, Monnatha Grego is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB316553

Account manager

Monnatha Grego
Brunel Canada - Calgary
m.grego@brunel.net

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