Job Title: PV Enablement Manager
Description:
The Regeneron Global Patient Safety Organization seeks a highly skilled and experienced Director, PV Enablement to join their team. As a key member of the organization, you will play a pivotal role in shaping the delivery of pharmacovigilance (PV) governance, ensuring operational requirements are met within a growing global PV platform.
In this dynamic and challenging role, you will work closely with the VP of GPS Operations to provide strategic oversight and deliver global PV governance in partnership with the GPS Leadership Team (GPS LT). You will be responsible for developing and maintaining operational reporting dashboards, providing status oversight for key GPS project initiatives, and collaborating with cross-functional teams to establish operational portfolio forecasting.
You will also partner with Regulatory Affairs, Development Quality, and Global Development teams to drive operational optimization activities, leveraging your expertise in pharmacovigilance to identify and assess operational risks across all areas of GPS. Your proactive approach to mitigation strategies will ensure seamless execution of safety initiatives and maintain regulatory compliance.
This is an exceptional opportunity to lead operational excellence initiatives, including benchmarking PV innovation and capabilities, and contribute to an enriching team environment that supports GPS culture, capability growth, and team development.
Required Skills and Qualifications:
1. Minimum Bachelor's Degree with 12+ years of relevant PV planning and operations experience in the pharmaceutical area and specific industry experience in managing and providing oversight of operations within a global patient safety organization
2. Function as a subject matter expert in global pharmacovigilance for GPS operations and planning
3. A proven ability to lead and develop a diverse remit in a constructive, goal-oriented environment, with continuous improvement and innovation mindset
4. Demonstrated problem-solving with the ability to