PV Strategic Partner Manager
- Basking Ridge, NJ
- Manage Strategic Partnerships and contracts including vendor outsourcing agreements, partner contracts PV Agreements (PVAs) [Safety Data Exchange Agreements (SDEAs)].
- Manage relationships with Contract Partners and Pharmacovigilance Information Exchange in Contractual Arrangements to ensure good Pharmacovigilance practice and regulatory compliance in such arrangements.
- Oversees the service provider and offshore unit responsible for call center, case management, medical writing and risk management support for client products, both investigational and marketed, to ensure accurate assessment and timely reporting of safety information.
- Serve as the key contact for the service provider and offshore unit to address and escalate issue requiring attention or resolution.
- Manage service provider and offshore unit to proactively drive operational excellence and continuous improvement.
- Measure and monitor performance of vendor and offshore unit against defined service levels and/or metrics to ensure timeliness, efficiency and quality of deliverables.
- Ensure service provider’s and offshore unit’s inspection readiness for inspections and audits of the Pharmacovigilance system.
- Maintain oversight for capability development of service provider and offshore unit resources.
Strategic Partner Management: Acts as subject matter expert in active contracts with strategic partners and vendor.
- Review & contribute to revision of contracts under negotiation (e.g. development, license, distribution agreements)
- Manage, negotiate, revise & document license partner safety agreements with counterparts from (license) partner companies
- Responsible for development and maintenance of a License agreement database
- Contribute to development of standard processes and contract templates in cooperation with Legal Department and PV functions
- Contribute to development of standards for information exchange with partners in cooperation with PV functions
- Initiate the implementation of obligations deriving from these contracts
- Organize and conduct a periodic review of contract quality and adherence
- Collaborate with audit groups to ensure comprehensive auditing of License Partners as required to assure compliance with PV agreement
- Manage CRO contracts including issue handling
- Coordinate PV participation in due diligence in acquisitions and divestment
- Negotiate and organize Transfer of Pharmacovigilance Business in case of Product Divestment
- Minimum of five (5) years of Drug Safety/Pharmacovigilance experience, including both investigational and marketed products;
- 3-4 years of direct experience in Pharmacovigilance Agreements, global setting preferred
- Knowledge of FDA regulations, clinical and safety databases
- Familiarity with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP)
- Ensures high-quality work is completed throughout the function and that internal and external expectations and timelines are met.
- Develops functional strategic plans, provides guidance on priorities within the function and leads implementation.
- Expertly identifies issues independently, thoroughly understands cause of issues, recognizes functional impact, develops and implements solutions.
- Expert scientific knowledge is used to provide leadership and to serve as subject matter expert throughout the function.
- Routinely interfaces, collaborates, and negotiates with project and functional leaders to drive results and resolve complex issues.
- Assists in driving timely management decisions, appropriately shifts functional timelines, resources and priorities to address regional needs.
- Bachelor’s degree in nursing, pharmacy, life sciences, health care or related field; PharmD, RN, or Master’s degree in life sciences preferred
Wednesday, May 6, 2020