The Associate Director, PV Strategic Partner Management will manage DSI's Strategic Partnerships and contracts including vendor outsourcing agreements, partner contracts PV Agreements (PVAs) [Safety Data Exchange Agreements (SDEAs)]. This position will be responsible for management of relationships with Contract Partners and Pharmacovigilance Information Exchange in Contractual Arrangements to ensure good Pharmacovigilance practice and regulatory compliance in such arrangements.
The individual will oversee the service provider and off-shore unit responsible for call center, case management, medical writing and risk management support for DSI products, both investigational and marketed, to ensure accurate assessment and timely reporting of safety information.
Maintains compliance with global Pharmacovigilance (PV) regulations for individual case safety reporting, periodic reporting and risk management. Serves as the key DSI contact for the service provider and off-shore unit to address and escalate issue requiring attention or resolution.
Manages service provider and off-shore unit to proactively drive operational excellence and continuous improvement.
Measures and monitors performance of vendor and off-shore unit against defined service levels and/or metrics to ensure timeliness, efficiency and quality of deliverables. Ensures service provider's and off-shore unit's inspection readiness for inspections and audits of the Pharmacovigilance system.
Maintains oversight for capability development of service provider and off-shore unit resources. Ensures adequate training of resources to enable quality and consistency of deliverables.
- Strategic Partner Management: Acts as subject matter expert in active contracts DSI has with strategic partners and vendor.
- Oversee and set standards for pharmacovigilance contract management.
- Review & contribute to revision of DSI contracts under negotiation (e.g. development, license, distribution agreements)
- Manage, negotiate, revise & document collaborative & license partner safety agreements with counterparts from (license) partner companies
- Responsible for development and maintenance of a License agreement database
- Lead development of standard processes and contract templates in cooperation with Legal Department and PV functions
- Drive 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 periodic review of contract quality and adherence
- Collaborate with DSI 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 diligences in acquisitions and divestment
- Negotiate and organize Transfer of Pharmacovigilance Business in case of Product Divestment
- Coordinate vendor assessments and make recommendations on vendor partners
- Direct and guide service provider and/or off-shore unit:
- Provide oversight for call center
- Provide oversight for case management activities including, but not limited to, Safety information submission to health authorities; global notification of safety information to Business Partners; Reconciliation with Patient Support Programs and Market Research vendors, Business Partners, Global Quality Supply Chain, Medical Information and other suppliers
- Prepare correspondence such as requests for additional information/targeted questionnaires
- Plan, allocate and utilize resources and prioritize assignments
- Manage quality, efficiency and resources for service provider and off-shore unit
- Measure and monitor performance of vendors against service levels and other metrics/KPIs
- Develop governance documents, business continuity plan, quality control plan, vendor monitoring plan
- Establish and maintain collaborative relationships with key stakeholders within CSPV and external functions including Clinical Development, Research & Development, Regulatory Affairs
- Serve as a leader in CSPV team with the ability to achieve results and meet goals by influencing others
- Participate in inspection and audit readiness activities
- Provide input for remediating PV system deficiencies cited during inspections/audits
- Management Strategy and Goals: Assist CSPV Leadership in developing PV goals, continued compliance, and strategy for process improvement initiatives.
- Aggregate Reports: Participates in the preparation and review of quarterly Case Processing Compliance and Volume Report. Manages the Aggregate Reports Coordinator and ensures the Case Processing team supports preparation of aggregate reports.
- Qualified candidates must have a Bachelor's degree from an accredited college or university; Bachelor's degree in nursing, pharmacy, life sciences, health care or related field
- Minimum of three (3) years of management experience in PV
- Minimum of ten (10) years of Drug Safety/Pharmacovigilance experience, including both investigational and marketed products
- Knowledge of AE and drug coding conventions (MedDRA, WHO-DD)
- Knowledge of FDA regulations, clinical and safety databases
- Familiarity with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP)
- PharmD, RN, or Master's degree in life sciences preferred
- 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.
- 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.
- Drives CAPA implementation with vendors and partners