Manager, Pharmacovigilance Alliance Contracting

Responsibilities

• 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).
• Collaborates with leadership of OCMO functional lines and PV Legal to drive relevant planning, execution, and governance of PVAs.
• Responsible for alignment with Business Development related to 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.
• Responsible for monitoring the alliance contract and managing contractual issues.
• Owns end-to-end process of development, execution, maintenance, and termination (when applicable) of PVAs and deliverables.
• Sets tactical approaches and drives effective operational plans for PVA negotiation and execution.
• Analyzes, evaluates, and leads implementation of process/technology improvements, digital tools, workflow automation, AI-enabled solutions, and data-driven enhancements.

• Minimum of a Bachelor’s degree in a relevant discipline, preferably Medical, Business or Legal qualification
• 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
• Applied knowledge of applicable Law and Regulations governing Pharmacovigilance on global level (e.g., HIPAA, EU PV Legislation, Code of Federal Regulations) (preferred)
• Working experience in a drug safety organization with operational responsibilities (preferred)
• Experience with technology platforms such as Power Apps or AI (preferred)