Pharmacovigilance Specalist

PUB304990

About this role

We’re hiring a Pharmacovigilance Specialist for a highly successful Global Pharmaceutical client located in Laval, Quebec . This is an office based role, you would be joining the PV team in the Laval office. This is a full time need long term need.

To be successful in the role, you would need to be a Bilingual with previous in-depth experience of Pharmacovigilance activities.
The Pharmacovigilance Specialist 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 / Clinical trial activities / Training) Ensuring appropriate contacts with Regulatory Affairs, Quality, Medical Affairs, and Global Pharmacovigilance.
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.
•To respond to queries and requests from Global Pharmacovigilance. •Interact with other functional areas/departments to process adverse events efficiently & reliably.
•To submit the reportable adverse reactions to Health Canada according to their regulations and guidance’s •To provide responses to questions from Health Canada and Health Care Professionals regarding adverse events cases.
•To collaborate in developing and maintaining the local Pharmacovigilance SOPs and procedures. •To review and submit Summary Reports to Health Canada according to their regulations and guidance’s
•To provide Pharmacovigilance input into labelling changes in conjunction with the Regulatory Affairs Department. •To have at disposal an updated list of all Canadian drug licensing status and renewals, in conjunction with Regulatory Affairs.
•To identify all local safety observational studies (-e.g., Phase IV studies), in conjunction with Regulatory Affairs. •To review and provide input into local contracts with third partners (licensing, distributor, etc.), in conjunction with Global Pharmacovigilance and maintain an updated list.
Clinical trials activities:
•To submit reportable adverse reactions to applicable divisions of Health Canada according to their regulations and guidance’s. •To inform Global Pharmacovigilance on all new local clinical trials and transmit the protocol if applicable.
Local regulations:
•To maintain current knowledge of all relevant local Pharmacovigilance regulations in regard to human and veterinary drugs and biological products •To participate in the screening of Health Canada’s website in conjunction with Regulatory Affairs.
•To educate internal stakeholders on the implications of existing regulations and guidance documents along with local and global procedures and policies. •Coordinate responses to questions and requests from Regulatory Authorities

Requirements

Qualifications:

  • Bilingual with great verbal and written communication
  • Degree within healthcare
  • Licensed Pharmacist within Quebec
  • Previous experience in a similar capacity
  • Advances software user

Benefits

What we offer
Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 44 countries. Advancing your career takes time and effort – let us match you to your ideal position.
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Any questions remaining?

Your consultant, Diana Grodowski is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB304990

Account manager

Diana Grodowski
Brunel Canada - Toronto
d.grodowski@brunel.net

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