Project Leader, Pharmacovigilance

Sanofi•Toronto, ON

8d•CA$127,000 - CA$177,000•Hybrid

About The Position

This position is responsible for leading activities in one or more of the following areas: management of PV requirements in patient programs and commercial projects, PV process optimization, local safety surveillance, quality assurance activities, participation in audits/inspections, local PV vendor oversight, Canadian and foreign case handling activities, risk management, quality system, training, compliance, PV systems, safety data exchange agreements, monitoring of emerging Canadian PV regulatory requirements, crisis management, medical safety management of local products. The PV Project Leader partners strategically with internal cross-functional teams by providing PV expertise and building close and robust relations with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and procurement.

Requirements

Pharmacy or Medical Degree: B. Pharm., B.Sc. Pharm., Pharm. D, MD. ; or license to practice medicine or pharmacy (Registered nurse with University degree or University degree in science and relevant experience and competency profile may be considered).
+2 years experience in the pharmaceutical industry or in a relevant Pharmacovigilance setting.
Other relevant experience in a Health Care setting may also be considered.
Action-oriented, able to work with constant short deadlines
Able to manage projects
Skilled with computer applications
Strong communication skills
Excellent analytical and problem-solving abilities
Excellent interpersonal skills
Strong organization and priority setting skills
Ability to focus on details where relevant whilst considering the global picture
Resourceful and able to take ownership of areas of responsibility
English, written and spoken
French an asset

Responsibilities

Contribute to the PV activities for Sanofi Canada.
Ensure compliance for PV requirements for patient programs and other commercial projects, including vendor oversight.
Responsible for quality assurance activities for the local PV vendor.
Contribute to the processing of domestic individual case safety reports (ICSRs) according to Corporate and Canadian requirements.
Contribute to the evaluation of domestic and foreign ICSRs for submission to Health Canada.
Handle safety related queries including crisis situations, and urgent Health Canada requests.
Partner strategically with internal teams.
Administer PV training programs to internal staff and external vendors.
Participate in compliance monitoring.
Organize and complete local safety surveillance activities.
Coordinate preparation, and submission of periodic safety update reports.
Develop local risk management strategies in close partnership with the Canada Risk Management Lead, global and local teams, and in accordance with Canadian requirements.
Organize a local quality system (SOPs) supporting PV activities.
Manage safety data exchange agreements.
Perform medical safety management of local products.