Manager, Pharmacovigilance Alliance Contracting

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at are searching for the best talent for a Manager Pharmacovigilance Alliance Contracting in High Wycombe UK.

Please note that this role is also available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all postings we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-081315

High Wycombe UK - Requisition Number: R-084639

Remember whether you apply to one or all requisition numbers your applications will be considered as a single submission.

Purpose:

Leads the J&J Innovative Medicine Office of the Chief Medical Officer (OCMO) in the negotiation contractual management and operational maintenance of Pharmacovigilance Agreements (PVAs). In collaboration with leadership of OCMO functional lines and PV Legal drive relevant planning execution and governance of PVAs. Responsible for alignment with Business Development related to the overall delivery of quality licensing agreement PV deliverables and participation in due diligence efforts. Contributes to PVA process improvement initiatives including technology-enabled transformation intelligent automation and data-driven decisions to improve compliance cycle times and quality.

You will be responsible for:

• Leads the PVA and New Business Integration/Divestment process: Responsible for monitoring the alliance contract and escalating as appropriate for contractual issues.
• PVA development - own end-to-end process of development execution maintenance and termination (when applicable) of PVAs and associated deliverables. May include strategy setting with input as necessary from functional line management.
• Sets tactical approaches and drive more effective operational plans for PVA negotiation and execution.
• Takes responsibility for a portion of the teams deliverables; may lead operational team(s); able to initiate conduct or lead PVA strategy meetings with minimal guidance.
• Analyzes evaluates and supports (or leads) the implementation of process/technology improvements including digital tools workflow automation AI-enabled solutions and data-driven enhancements (e.g. dashboards/metrics) that increase efficiencies and effectiveness across PVAs and product divestitures while maintaining appropriate governance and compliance in regulated environments.
• Defines and champions fit-for-purpose governance standards and enablement (training/support) for tools used to manage PVAs (e.g. workflow tracking reporting) ensuring scalable adoption and consistent execution.
• Maintain group workflow management tracking tool and other tools as necessary.
• Responsible for managing and tracking due diligence responsibilities for acquisitions alliances and divestitures on behalf of OCMO. Upon request from Pharmaceutical Business Development participate in Due Diligence (Licensing & Acquisitions Mergers & Acquisitions) efforts; evaluate the pharmacovigilance process and product safety components of global /regional product and/or company licensing and/or acquisition opportunities.
• Contact List appendix updates.
• Flag emerging issues in licensing relationships with other companies; and ensure the PAC Team Lead and the PAC Team are aware.
• Manages PV alliance relationships and takes action where (potential) issues might arise. Escalates issues applying judgment. The goal is to optimize and sustain Alliances with the minimal necessary resources.

Qualifications / Requirements:

Education:

• Minimum of a Bachelors degree in a relevant discipline preferably Medical Business or Legal qualification
• Masters degree is preferred

Required:

• Minimum of 6 years of relevant experience
• Minimum of 3 years of pharmacovigilance experience
• Proven experience in group facilitation - ability to lead and drive teams to make decisions & achieve deliverables within agreed parameters & timelines
• Demonstrated experience in program management preferably in pharmaceutical business environment
• Proficiency with contract language and standard legal terms and conditions for commercial contracts
• Demonstrated problem solving ability
• Strong organizational and coordination skills
• Excellent presentation writing communication and computer skills
• Excellent negotiation and networking skills

Preferred:

• Applied knowledge of applicable Law and Regulations governing Pharmacovigilance on global level (e.g. HIPAA EU PV Legislation Code of Federal Regulations)
• Working experience in a drug safety organization with operational responsibilities
• Experience with technology platforms such PowerApps or AI

#LI-Hybrid

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