Director, Pharmacovigilance

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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.

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,

Our Base Pay Range for this position

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.

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