Director, Pharmacovigilance

1 week ago

Mississauga, Ontario, Canada McKesson Full time

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care.

What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you.

Job Summary
The Director of Pharmacovigilance (PV) is responsible for leading the pharmacovigilance function across the organization, ensuring compliance with global regulatory requirements, manufacturer and client contractual obligations and internal McKesson policies. The incumbent will be providing strategic direction to the Pharmacovigilance workstream within Project Criterion and will be responsible for gaining alignment and providing direction to future workflows implementing best PV practices within the Patient Support Programs (PSP), Specialty Pharmacies, and INVIVA clinics. This role oversees the operational team responsible for detection, assessment, training, reporting, and reconciliation of adverse effects. The Director will manage a team of safety professionals and collaborate cross-functionally with regulatory, clinical, medical affairs, and commercial teams to ensure patient safety and regulatory compliance. This role is critical in shaping the strategic direction of the pharmacovigilance program and serves as the key contact for regulatory authorities and manufacturer clients.

Key Responsibilities
Strategic and Operational Leadership

  • Lead the development and execution of Specialty Health's pharmacovigilance strategy.
  • Lead the development and execution of all pharmacovigilance practices in Project Criterion.
  • Ensure compliance with local and international pharmacovigilance regulations (e.g., FDA, Health Canada, EMA).

Team and Cross-Functional Management

  • Supervise and mentor a team of PV associates and specialists, AE case processors, and PV manager.
  • Oversee the collection, evaluation, and reporting of adverse events and safety data from all 3 Specialty Health operational teams.
  • Collaborate with regulatory affairs, clinical development, medical affairs, and quality assurance to align safety strategies.
  • Provide leadership in the development and maintenance of safety databases and signal detection tools.

Compliance and Risk Management

  • Monitor changes in global pharmacovigilance regulations and implement necessary updates to internal processes.
  • Lead the preparation and submission of periodic safety update reports (PSURs), development safety update reports (DSURs), and risk management plans (RMPs).
  • Ensure timely and accurate reporting of individual case safety reports (ICSRs) and aggregate safety data.
  • Leads the evolution of Specialty Health's pharmacovigilance practices to become a key differentiator in various business opportunities.

Stakeholder Engagement

  • Serve as the primary point of contact for regulatory and manufacturer inspections and audits related to drug safety.
  • Reviews, negotiates and prepares for sign off all pharmacovigilance-related contracts with clients.
  • Represent the company in interactions with regulatory agencies, partners, and external stakeholders.
  • Provide safety input into product labeling, promotional materials, and clinical trial protocols.

Minimum Qualifications

  • Advanced degree in a health-related field.
  • Minimum of 8–10 years of experience in pharmacovigilance or drug safety.
  • Minimum 3 years in a leadership role.
  • Proven experience managing regulatory inspections and audits.
  • Strong understanding of global PV regulations and ICH guidelines.

General Responsibilities

  • Certification in pharmacovigilance or drug safety is an asset.
  • Excellent leadership, communication, and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Proficiency in safety databases and Microsoft Office tools.
  • Ability to work cross-functionally and influence without authority.
  • High attention to detail and commitment to quality.

McKesson welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here.

Our Base Pay Range for this position
$124,800 - $208,000

McKesson is an Equal Opportunity Employer
McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

Join us at McKesson

  • Director, Scientific Affairs

    6 days ago

    Mississauga, Ontario, Canada Shoppers Drug Mart Full time

    Location: 1685 Tech Ave, Mississauga, Ontario, L4W 0A7At Shoppers Drug Mart, we're innovating health and wellness in Canada. From prescriptions to walk-in clinics, and a beloved loyalty program, we're caring and supporting our customers in new ways every day.With more than 1,300 locally owned and operated stores from coast to coast, the Shoppers Drug Mart...

  • Sr. Director/Director Data Intelligence

    2 weeks ago

    Mississauga, Ontario, Canada Ergomed Full time

    Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory...

  • Director, Scientific Affairs

    3 days ago

    Mississauga, Ontario, Canada Shoppers Drug Mart Specialty Health Network Full time

    Location:1685 Tech Ave, Mississauga, Ontario, L4W 0A7At Shoppers Drug Mart, we're innovating health and wellness in Canada. From prescriptions to walk-in clinics, and a beloved loyalty program, we're caring and supporting our customers in new ways every day.With more than 1,300 locally owned and operated stores from coast to coast, the Shoppers Drug Mart...

  • Associate Director, Regulatory Affairs

    1 week ago

    Mississauga, Ontario, Canada Novo Nordisk, Inc. Full time

    Associate Director, Regulatory AffairsCategory: Reg Affairs & Safety PharmacovigilanceLocation:Mississauga, Ontario, CAClinical, Medical & Regulatory DepartmentMississauga, CanadaAre you passionate about regulatory affairs and ensuring compliance in the pharmaceutical industry? Do you have a strong strategic vision and leadership skills to drive in an...

  • Director, Safety, Health, Environment and Quality

    2 weeks ago

    Mississauga, Ontario, Canada Linde Full time

    Required Qualifications:Education:University degree in Occupational Health and Safety, Environmental Science, Engineering, Science or a related field.Advanced degree (e.g., Master of Safety) is preferred.Relevant certifications (e.g., Six Sigma, ASQ, Lean, etc.) are preferred. Experience:Significant operations and & or experience with at least 15+ years in...

  • Director, Safety, Health, Environment and Quality

    7 days ago

    Mississauga, Ontario, Canada Linde Full time

    Linde is a leading global industrial gases and engineering company with 2024 sales of $33 billion. We live our mission of making our world more productive every day by providing high-quality solutions, technologies and services which are making our customers more successful and helping to sustain and protect our planet. The company serves a variety of end...

  • Medical Science Liaison

    2 days ago

    Mississauga, Ontario, Canada BioSyent Inc Full time

    Are you an expert in and passionate about Medical Affairs in pharmaceutical products? Would you like to apply your expertise to make a meaningful impact in a company that prioritizes scientific innovation and transforms ideas into solutions for the Canadian market? If so, we invite you to contact usWe're BioSyent and we are looking fora Medical Science...

  • Medical Science Liaison

    2 days ago

    Mississauga, Ontario, Canada BioSyent Pharma Inc. Full time

    Are you an expert in and passionate about Medical Affairs in pharmaceutical products? Would you like to apply your expertise to make a meaningful impact in a company that prioritizes scientific innovation and transforms ideas into solutions for the Canadian market? If so, we invite you to contact usWe're BioSyent and we are looking for a Medical Science...

  • Director, Pharmacovigilance

    4 weeks ago

    Mississauga, Canada McKesson Full time

    McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care.What you do at McKesson matters. We foster a...

  • Director, Pharmacovigilance

    4 weeks ago

    Mississauga, Canada McKesson Full time

    McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care. What you do at McKesson matters. We foster a...

  • Director of Pharmacovigilance

    7 days ago

    Mississauga, Canada McKesson Full time

    A global healthcare leader is seeking a Director of Pharmacovigilance in Mississauga to lead compliance and regulatory efforts. This role requires strong leadership, extensive experience in drug safety, and knowledge of global regulations. The successful candidate will manage a team and collaborate across functions to ensure patient safety. Competitive...

  • Director of Pharmacovigilance

    7 days ago

    Mississauga, Canada McKesson Full time

    A global healthcare leader is seeking a Director of Pharmacovigilance in Mississauga to lead compliance and regulatory efforts. This role requires strong leadership, extensive experience in drug safety, and knowledge of global regulations. The successful candidate will manage a team and collaborate across functions to ensure patient safety. Competitive...

  • Serm Scientific Director

    5 days ago

    Mississauga, Canada GSK Full time

    **Site Name**: GSK HQ, Canada - Ontario - Mississauga, UK - Hertfordshire - Stevenage, Warsaw **Posted Date**: May 14 2025 **SERM Scientific Director** Are you interested in a highly visible, strategic role that allows you to support the pharmacovigilance and benefit-risk management of assigned GSK global assets to ensure Patient Safety globally.? If so,...

  • Director, Scientific Affairs

    3 days ago

    Mississauga, Canada Shoppers Drug Mart Specialty Health Network Full time

    Director, Scientific Affairs & Quality Assurance 1685 Tech Ave, Mississauga, Ontario, L4W 0A7 Why this role is important? Reporting directly to the Senior Director, Quality Assurance, the incumbent will be responsible for strategic leadership and functional management of quality assurance, drug safety / pharmacovigilance and compliance governance at Shoppers...

  • Executive Medical Director/SERM Head

    2 weeks ago

    Mississauga, Canada 1054 GlaxoSmithKline Services Unlimited Full time

    Executive Medical Director / SERM Head - OncologyWe are seeking a visionary and strategic leader to join our Global Safety Evaluation and Risk Management team as SERM Head, Executive Director. This is a critical leadership role responsible for shaping and driving the clinical safety and pharmacovigilance strategy across our Oncology portfolio, ensuring the...

  • Serm Scientific Director, Oncology

    1 week ago

    Mississauga, Canada GSK Full time

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, Mississauga, Warsaw Rzymowskiego 53 **Posted Date**: May 9 2025 **Job Purpose**: Responsible to lead medical and scientific staff within the SERM (Safety Evaluation & Risk Management) and defining and driving the strategy and vision of clinical safety and pharmacovigilance activities in...

  • Icsr Operational Lead

    2 weeks ago

    Mississauga, Canada PrimeVigilance Full time

    **Company Description** We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...

  • Director, Scientific Affairs

    3 days ago

    Mississauga, Canada Shoppers Drug Mart Full time

    Location: 1685 Tech Ave, Mississauga, Ontario, L4W 0A7 At Shoppers Drug Mart, we’re innovating health and wellness in Canada. From prescriptions to walk-in clinics, and a beloved loyalty program, we’re caring and supporting our customers in new ways every day.With more than 1,300 locally owned and operated stores from coast to coast, the Shoppers Drug...