PV Alliance Senior Manager
This position reports into the Office of the Product Safety Team (PST) within the Pharmacovigilance and Patient Safety (PPS) organization's Global PV Strategy Management Office. The PPS organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand and communicate the safety profile of our drugs to protect patients worldwide.
The PV Alliance Team is a high-profile high-impact team that owns Safety Data Exchange Agreements (PV Agreements) and leads the PV Agreement strategy across the product lifecycle. The PV Alliance team plays a critical role partnering with internal stakeholders and external partners across the product lifecycle to ensure appropriate and timely exchange of Safety information to maintain regulatory compliance.
As a PV Alliance Senior Manager within the Office of the PST, you are in a highly visible role that provides various opportunities to drive the strategy and development of Safety Data Exchange Agreements and related business processes and technologies.
- Independently executes negotiation of complex; multi-partner PV Agreements with internal Stakeholders and external Partners within the appropriate timeline.
- Proactively identifies and escalates potential compliance related issues that may impact the ability to meet regulatory requirements and business goals; leads development and implementation of methods of improvement and resolution.
- Drives inspection readiness activities by conducting SDEA audit and inspection preparation meetings. May act as the primary contact and subject matter expert for audits/inspections, ensuring document requests and responses are filled in a timely manner.
- Builds enterprise knowledge around PV alliance processes & systems utilized to create & execute PV Agreements
- Interprets current and emerging guidance and regulations that impact Individual Case Safety Reporting (ICSR) and Safety Deliverables. Reviews new legislation and identifies recommended actions (where applicable) to ensure compliance with regulations.
- Collaborates independently across functions and organizations to ensure timely communication of ICSR and Safety Deliverables to Partners.
- In conjunction with the Business Process Office drives timely reporting and exchange of safety deliverables through metric evaluation, tracking and trending. Develops and revises Quality System Documents.
- Serves as the business lead in process improvement initiatives driven by the Business Process Office, and supports process documentation, training, CAPAs and metrics
- Plans and conducts best practice and knowledge sharing forums with internal stakeholders and external advisory groups.
- Provide PV Alliance support as applicable to enable PPS readiness for product launches
- May be responsible to oversee contract personnel.
- Bachelor's degree required (with related health science or legal disciplines preferred)
- Masters or advanced degree is desirable
- At least 4 years' experience working in the pharmaceutical industry and a strong background in pharmacovigilance contract negotiation.
- Proven experience with External Partner Relationship Management.
- Demonstrated leadership experience.
- Strong leadership Presence. Ability to work directly with and influence senior management including internal key stakeholders such as Business Alliance, Legal, Commercial, Organized Data Collection and Quality.
- Demonstrated ability to work and collaborate with others, to consider the needs of all impacted groups, and to build/leverage relationships across functions and organizations to achieve business results. Decisive yet collaborative leadership style.
- Established track record leading cross-functional projects within a global company .
Equal Opportunity Employer Minorities/Women/Veterans/Disabled