Head of Medical Information & Pharmacovigilance (Canada)

Position Summary
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.

Key accountabilities

• 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.

Key deliverables

• ICSR processing and regulatory reporting meet timeliness and quality metrics.

• Completion and timeliness of Canada Annual Summary Reports and Risk Management Plans.

• Effective and timely safety communications

• Inspection-ready PV/MI systems with positive audit/inspection outcomes and timely CAPA closures.

• Service Level Agreement adherence and strong vendor performance for MI/PV third-party providers.

• Training completion rates and team capability/retention.

Why You?

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• 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.

Preferred Qualification
If you have the following characteristics, it would be a plus

• 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.

Key stakeholders

• Internal: Country Medical Director, General Manager, Medical Division Leadership Team, Regulatory Affairs, Legal, Quality Assurance, Commercial Operations, Medical Affairs, Reimbursement, Public Affairs and ViiV teams.

• External: Global Safety / Regional PV Operations, Global Service Providers, CROs, Health Canada, ethics committees and investigators.

Working Model
This role is located in Mississauga, Canada and will follow a hybrid working model. You will combine office and remote work. Specific on-site days will be agreed with your manager to support collaboration, governance and inspection readiness.

What you will gain
You will grow your skills in safety operations, stakeholder engagement and process leadership. You will make a meaningful contribution to patient safety in Canada. You will join a team that values inclusion, clear communication, and continuous learning.

How to apply
If this role fits your skills and ambitions, please apply. Share your CV and a short note explaining what excites you about this role and how you would contribute to local safety and medical information. We look forward to hearing from you.

#LI-Hybrid

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com.  Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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