Director, GPS Aggregate Report Mgt and Risk Mgt Planning

Tarrytown, NY, United States
Jun 11, 2021
Administration, General
Required Education
Bachelors Degree
Position Type
Full time
The Director of Global Patient Safety (GPS), Aggregate Report Management and Risk Management Planning is a key role within the GPS organization in the Case Evaluation and Reporting (CER) area and will be responsible for developing and maintaining a Center of Excellence (CoE) for aggregate reporting and risk management planning.

As part of GPS team, the Director will collaborate across GPS and the broader organization including regulatory affairs, clinical operations, and medical affairs to drive strategic planning and project management of safety reporting results across the Regeneron portfolio. You will ensure quality and compliance/metrics through the development and maintenance of scheduling reporting activities, kick-off meetings for aggregate reports, risk management plans, Health Authority Responses and tracking/management of achievements
In this role, a typical day might include the following:

Responsible for oversight of activities related to aggregate reporting (PSUR/PBUR, DSUR, SUSAR/SARs, PAER), Risk Management Plans, HA responses, CAPAs, audits/inspections and other PV results

Maintenance of Aggregate Report Calendar, RMP Tracker, RMM List and HA Response Tracker

Ensure efficient and robust procedures to drive quality, timeliness and compliance with regulations

Coordinate and maintain dashboards around organizational compliance, performance and quality and serves as a key partner to GPS's Quality Compliance and Business Support team

Supervise for resource gaps or delays with PV result process and aggregate report project plans

Provide appropriate feedback to PV colleagues for process on aggregate reports to ensure quality

We need the implementation of and supervision of key performance indicator (KPIs) results

Provide oversight of outsourcing vendors as applicable

Collaborate with internal and external partners as well as TAL in the management of deliverables including all aggregate reports and risk management plans.

Ensure the tracking and management all key achievements

Ensure accurate and timely notification to Teams for all reports

Ensure cross-functional assignment of all activities related to results

Proactively follow up with Action Owners and Contributors

Liaise with other functions to ensure information is forwarded in a timely fashion
This role might be for you if:
  • 10+ years of industry experience with a minimum of a Bachelor's degree, science-based degree preferred (PharmD., pharmacy or nursing degree)
  • Excellent leadership skills, strategic decision-making and analytical skills with a demonstrated ability to drive alignment on goals across teams, holding people accountable in a constructive manner and taking care of senior leaders of the company
  • We seek a track record of building an organization capability or leading a Center of Excellence (CoE) model in pharmacovigilance
  • An ability to build positive relationships across team areas as a trusted advisor through the demonstration of extensive knowledge of US, ICH and EU PV and GCP regulations
  • Experience with regulatory inspections (PV and GCP), managing pharmacovigilance vendors and working with Alliance Partners and managing pharmacovigilance agreements
  • Experience with managing vendors
  • Skilled in all aspects of Microsoft Teams

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.