Head of Medical Information & Pharmacovigilance (Canada)

GSK•Mississauga, ON

4d•Hybrid

About The Position

The Head of Medical Information & Pharmacovigilance (Canada) is accountable for oversight and day-to-day management of Medical Information (MI) and Pharmacovigilance (PV) activities across the Local Operating Company to ensure patient safety, regulatory compliance and alignment with Global Safety, Regional PV Operations and local regulations. You will serve as the Named Safety Contact (NSC) for Canada, is a member of the Medical Division Leadership Team and acts as the primary local liaison with Global Safety, Regional PV Operations and Health Canada.

Requirements

University degree in healthcare (MD, PharmD, Pharmacy, Nursing or equivalent).
Minimum 5 years’ experience in the pharmaceutical industry with relevant PV/MI exposure.
Demonstrated experience interacting with Health Canada on critical safety/regulatory issues.
Strong working knowledge of Canadian and international PV regulations, PV systems and ARGUS.
Regulatory and technical PV expertise with strong clinical judgement.
Risk-based decision making and ability to balance medical and business imperatives.
Audit/inspection readiness, quality mindset and continuous improvement orientation.
Excellent communication, crisis management and escalation skills.

Nice To Haves

Experience with vaccines and/or therapeutic area experience.
3+ years’ direct people management experience.
Bilingual (English/French) is an asset.
Experience working with Global Service Provider(s), CROs, and cross-functional stakeholders.

Responsibilities

Serve as the Named Safety Contact (NSC) for Canada with overall responsibility for pharmacovigilance for marketed and investigational products.
Through implementation of a local PV oversight strategy, ensures all local PV activities are compliant including but not limited to training, regulatory intelligence, risk management plans, aggregate and individual expedited reports, safety communications, PV agreements and safety clauses and commercial/medical activities.
In collaboration with the Country Medical Director, support the General Manager oversight of Enterprise Patient Safety Risk
Act as a member of the Medical Division Leadership Team, relevant global committees and serve as primary liaison with Global Safety functions and Regional PV Operations for process alignment and implementation.
Provide leadership and strategic input on MI and PV matters to support local business objectives.
Provide leadership for Medical Information activities for the creation and maintenance of local MI content, ensuring the awareness of Canadian specific information and updates.
Serve as primary contact with the Health Canada Special Access Program for establishing new programs and maintaining up to date information on existing programs
Provide strategic partnerships to Legal, QA, Commercial Operations, Public Affairs, Reimbursement and Regulatory Affairs to ensure effective delivery from third-party service providers.