Associate Manager Global Patient Safety

Responsible for supporting pharmacovigilance operations in the successful management of vendor and case processing deliverables in accordance with applicable regulations and agreements

Responsible for successful conduct of case processing activities for all investigational and marketed products to ensure timely processing of adverse events reports as described in the FDA Code of Federal Regulations, Regeneron Licensing Partners Safety Data Exchange Agreements and SOPs. Supports new/ongoing phase IV/post-marketing studies

In this role, a typical day might include the following:

• Interacts with case processing vendor on regular basis to ensure timely processing of adverse events reports for all investigational and marketed products.
• Evaluates all adverse event reports received from the case processing vendor for accuracy and regulatory reporting.  Monitors case finalization work stream and prepares reports for distribution.
• Performs vendor oversight activities by monitoring vendor's case processing quality and compliance metrics
• Independently interacts with LPs as needed to support case processing deliverables in accordance with applicable regulations in accordance to license partner agreements
• Works closely with medical affairs personnel for PV deliverables related to post-marketing studies/programs
• Works closely with Regulatory personnel for regulatory submissions of adverse event reports.
• Liaise with Medical Information and Commercial leads to manage vendors and personnel directly involved with CERM deliverables
• Exercises independent judgment in managing case processing deliverables and maintaining compliance with SOPs, LP agreement and applicable worldwide regulations to ensure timely and consistent deliverables.
• Leads and/or contributes to continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies applicable to internal CERM deliverables.
• Ensures development and maintenance of applicable SOPs, Working Practices and trainings.
• Frequently interacts with collaborators, and functional peer groups at various management levels within and outside the organization to support vendor management and case processing deliverables. Interaction typically requires the ability to gain cooperation of others, conducting presentations of safety related information concerning specific projects or schedules.

This role might be for you if:

• Working knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
• Subject Matter Expert for case processing.
• Knows when to escalate an issue and has the ability to apply critical thinking if timelines are at risk
• Bachelor’s degree
• Minimum 2 years case processing experience

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.