Global Pharmacovigilance Manager – Managed Access Programs

Company & Role Description

Founded in 2002, Tanner Pharma Group is a specialty service provider in the biopharmaceutical industry focused on improving patient access to medicines on a global basis. Tanner Pharma offers its biopharmaceutical partners a portfolio of four distinct service offerings that span the product lifecycle from clinical development to commercialization. With its global headquarters in Charlotte, North Carolina and offices in the United Kingdom, Switzerland and Ireland, Tanner Pharma is in a phase of rapid growth.

We are looking for a pharmacovigilance (PV) expert to join our team and support our Managed Access Programs (MAP) division with all PV matters. You have the opportunity to join a dynamic, growing company, making a difference in patients’ lives.

Responsibilities

• Provide expert advice to internal and external parties on pharmacovigilance matters for named patient use supply and other managed access programs to ensure compliance with applicable PV regulations.
• Lead the negotiation and establishment of pharmacovigilance agreements, clearly defining roles, responsibilities, and conditions to enable seamless collaboration.
• Oversee and manage pharmacovigilance collaborations with external program sponsors and service providers, ensuring adherence to pharmacovigilance agreement responsibilities.
• Represent the Pharmacovigilance function in internal and external meetings, providing updates, insights, and guidance on pharmacovigilance matters.
• Liaise with program sponsor pharmacovigilance contacts on related matters.
• Provide subject matter expertise on current and evolving pharmacovigilance regulations and guidelines, both internally and externally.
• Manage and maintain Tanner’s internal database on pharmacovigilance regulations; monitor changes to applicable regulations.
• Lead pharmacovigilance audits and inspections related to collaborations, including contribution to corrective and preventive action (CAPA) plans.
• Manage the periodic safety data reconciliation process with external program sponsors and service providers.
• Train and educate internal teams on pharmacovigilance standards, procedures, and collaboration requirements.
• Identify opportunities for process improvement, efficiency gains, and risk mitigation across pharmacovigilance operations.
• Support team on other regulatory matters relevant to managed access programs.

Desired Candidate Profile & Capabilities

• A bachelor’s degree or higher in life sciences, pharmacy, or a related field.
• At least 5 years of experience in pharmacovigilance or regulatory compliance
• Strong knowledge and expertise in global PV regulations
• Prior experience working with external parties and regulatory authorities on pharmacovigilance matters
• Ability to translate complex PV concepts and regulatory requirements into clear, client-friendly communications and presentations
• Prior experience with named patient supply and managed access programs
• Proficient in leveraging AI tools to drive efficiency and deepen regulatory analysis
• High attention to detail
• Ability to manage multiple projects, prioritize, and consistently meet deadlines
• The ability to work independently and collaboratively in a fast-paced environment.
• A dynamic, flexible and problem-solving attitude.
• Proficiency in written and spoken English; knowledge of other languages is advantageous
• Prior regulatory compliance experience with named patient supply considered a plus

Soft skills:

• Communication: able to communicate in a clear, appropriate, effective and efficient manner in various situations
• Problem-solving: able to handle difficult or unexpected situations in the workplace as well as complex business challenges
• Leadership: ability to encourage, motivate, inspire and challenge others to produce their best work while working toward common goals.
• Negotiation & Persuasion Skills: Being able to discuss and reach a mutually satisfactory agreement & convincing others to take appropriate action.
• Detail-Oriented : ability to accomplish/complete tasks while demonstrating a thorough concern for all the areas involved, no matter how small.

Compensation & Benefits:

• Pension scheme
• Private health insurance
• Attractive performance incentive plan
• Vacation, Volunteer and paid sick leave
• Competitive salary

Tanner Pharma Group’s Core Values: Everything we do at Tanner Pharma Group is dictated by our values. We take them very seriously, and we’re proud of this unwavering commitment.

Check out https://www.tannerpharma.com to view our core values and learn more about our company.

Candidates may be required to organize reference calls upon request. Confidentiality will be respected. Additionally, Pre-employment drug and background screening will be required.

Tanner Pharma Group is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Job Types: Full-time, Temporary

Benefits:

• Company events
• Company pension
• On-site parking

Education:

• Bachelor’s (required)

Experience:

• Global Pharmacovigilance regulations: 4 years (required)
• Named patient supply: 3 years (preferred)
• Managed access programs: 3 years (preferred)

Work Location: Remote

Apply Now