Pharmacovigilance Team Lead

PUB323316

About this role: Pharmacovigilance Team Lead

About this role: Pharmacovigilance Team Lead

We’re hiring a Pharmacovigilance Team Lead 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. We’re looking for local professionals or someone willing to relocate.

The Pharmacovigilance Team Lead is responsible for maintaining an efficient vigilance system in compliance with the Health Canada regulations and guidelines participating in other Pharmacovigilance processes (e.g., Post-market surveillance activities / Training) Ensuring appropriate contacts with Regulatory Affairs, Quality, Medical Affairs, and Global Pharmacovigilance.

Responsibilities

  • Responsible for the oversight of Brunel staffs local PV activities.
  • 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 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.
  • 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.

Post-market surveillance activities:

  • To collect, pursue follow-up information to complete quality adverse event reports and transmit all local adverse events to Global Pharmacovigilance.
  • To document and update case information into the global safety database.
  • Analyze and process adverse events and safety reports with utmost quality and timeliness in accordance with Global and Local Pharmacovigilance procedures.

Requirements

Requirements

Requirements

  • Bilingual with great verbal and written communication
  • Degree within healthcare (Pharmacy or Medical Degree: B. Pharm., B.Sc. Pharm., Pharm. D, MD. (Registered nurse with University degree or University degree in science and relevant experience and competency profile may be considered))
  • Previous experience in a similar capacity
  • Advanced software user
  • 3-years’ experience in a relevant Pharmacovigilance setting in the pharmaceutical industry. Other relevant experience in a Health Care setting may also be considered.

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:
PUB323316

Account manager

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

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