Director, Pharmacovigilance
Director, Pharmacovigilance
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$ 124800 - 208000
1 Vacancy
Job Description
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 tomorrows 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 Healths 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 Healths 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 810 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 McKessons 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 pleaseclick here.
Our Base Pay Range for this position
$124800 - $208000McKesson 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 McKessons full Equal Employment Opportunity policies visit our Equal Employment Opportunity page.
Join us at McKesson!
Required Experience:
Director
Employment Type
Full-Time
