Pharmacovigilance Assistant

PUB314373

medical device pharmaceutical food industry

About this role

About this role

We’re hiring a Pharmacovigilance Assistant with our client, a global pharmaceutical company, to join their team. This is a 1-year contract renewable and home-based opportunity for now, however it will be required to go to the office some days a week. This professional will be supporting the Pharmacovigilance department.

Responsibilities

  • Forward ICSRs (initial, follow-up, serious, non-serious, solicited, non-solicited, drug, medical device) to GPE (Global Pharmacovigilance and Epidemiology) or licensed partners as per corporate and local requirements and timelines.
  • Process CIOMS reports received from GPE for domestic and international cases in preparation for evaluations by PV specialists. Following evaluations by PV specialists, process reports for submitting to Health Canada.
  • Ensure that all ICSRs for drugs and medical devices subject to expedited reporting according to Canadian regulations are submitted to Health Canada within prescribed timelines. PV specialists will identify such ICSRs as well as deadlines.
  • Prepare written follow-up requests for ICSRs as per corporate and local requirements.
  • Document in the local PV tracking database (Remedy) all activities related to Canadian ICSRs and international reportable ICSRs.
  • Process medical device ICSRs and PTCs (Product Technical Complaints) as per local and corporate requirements, including ICSRs from the Lantus Pen Call Centre. Maintain paper and electronic filing of such activities, including data entry in the local PV tracking database.
  • Maintain paper files for all PV activities as per Canadian and corporate requirements and according to GDP (Good Documentation Practices).
  • Maintain an accurate and efficient electronic filing system for all PV activities to ensure efficient functioning of the team.
  • Participate in the administration of the PV tracking database (Remedy) including modifications, corrections, and adjustments for continuous improvement of the system.
  • Participate in the development of quality documents (e.g. working documents) describing the technical steps of coordinator activities.
  • Provide overall support to the PV team, including the PV Head and PV specialists, on all team activities

Requirements

Requirements

Requirements

  • 1 year of Pharmacovigilance experience and a bachelor’s degree in a related field
  • OR Bachelor’s degree in Pharmacy and experience in related field
  • Ability to work in a group setting and independently, good teamwork skills
  • Good communication and analytical skills
  • English required; French is desirable.

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.

About Brunel

People in a meeting room

About Brunel

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.

How to apply

How to apply

If you meet the above requirements and would like to be considered for this role, please submit your interest using the ‘Apply’ button. Applying is quick and easy – just make sure you have the following documents ready to go:

  • Resume
  • Cover Letter (optional)
Apply now

Do you have questions?

If you have questions or would like to discuss the details of this role, please contact Monnatha Grego via the details below, quoting publication number:
PUB314373

Account manager

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

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