Pharmacovigilance Coordinator

Laval - Quebec - Canada - Life Sciences & Health Care - Pharmaceutical - Regulatory - Academic Bachelor

We’re hiring a Pharmacovigilance Coordinator for our client, a large pharmaceutical company, to join their team. This is a long-term contract.

Feel free to contact

Diana Grodowski, Account manager

Apply now

About this role

Responsibilities

  • Data Entry of ICSRs (initial, follow-up, serious, non-serious, solicited, non solicited, drug, medical device) to GPV (Global Pharmacovigilance) or licensed partners as per corporate and local requirements and timelines.
  • Process CIOMS reports received from partners 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 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 Diabetes Call Centre. Maintain paper and electronic filing of such activities, including data entry in the local PV tracking database.
  • Perform reconciliations of PSP programs as per corporate requirements.
  • 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.

About you

Requirements

  • Science degree (BSc.), (Preferred: BSc. Biology, Pharmacology; Nursing, Pharmacy)
  • 1-3 years Canadian Pharmacovigilance, Quality or Regulatory experience. Candidates with other relevant experience or new university graduates may also be considered.
  • Capable of multi-tasking,
  • Above average computer skills.
  • Excellent organizational and communication skills with multiple audiences (e.g., Health Canada, internal departments, Health Care Professionals and patients).
  • Operates effectively in a team environment
  • Ability to work under strict deadlines and changing priorities with limited supervision
  • Attention to detail
  • Understanding of existing regulations and guidance
  • Must be bilingual (English, French)

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Vacancy number: PUB219587
  • Location: Laval
  • Market: Life Sciences & Health Care
  • hours per week: 35
  • Branche: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of Expertise: Regulatory
  • Closing date: Thursday, August 15, 2019
Apply now

Feel free to contact

DG

Diana Grodowski

Account manager Brunel Canada Toronto

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