Associate Director, Aggregate Reporting

This position of Associate Director, Global Patient Safety with focus on Aggregate Reporting Management resides in the Global Patient Safety (GPS) organization of Regeneron in the Case Evaluation & Reporting (CER) area and would be responsible for oversight and management of Aggregate Reports.

In this role, a typical day might include:

Drives development and maintenance of Aggregate Reporting (i.e., PSURs/PBRER, PAER, DSURs, SUSARs) Deliverables.

Leads Aggregate Reports planning, production and distribution activities across GPS and other functions

Support the authoring and review of periodic aggregate safety reports, including but not limited to PBRER/PSUR, PADER, DSUR, ASRs, HA Responses

Assess Aggregate Reports requirements and complexity, to identify potential issues and information gaps and support resolution of any identified issues

Lead the enhancement of Quality Control process for Aggregate Reports

Support the development and maintenance of procedural documents (SOPs, BPTs, etc.)

Lead the development of templates for Aggregate Reports. Provides expertise and guidance to authors and contributors of aggregate reports

Responsible for maintaining compliance metrics and contributes to implementation of Corrective Action and Preventive Action (CAPA) for non-compliance

Responsible for the implementation and management of effective structure, procedures, and tools to ensure aggregate reports and other functional deliverables are completed timely and with high quality

Oversee functional specifications of data requirements for aggregate deliverables from the safety and clinical databases

Collaborates with Global Patient Safety (GPS) and with functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) contributing to aggregate safety reports

Assists in preparation and support of audits and inspections Provides oversight, and training as needed, of CRO respective activities in support of high quality and timely aggregate reports

This role might be for you if you have:

Strong project management skills

Excellent strategic decision-making and analytical skills

Excellent decision making and judgment

Strong communication and writing skills

Project management experience strongly preferred, PMP preferred

Case processing and safety systems experience preferred

Experience working with Alliance Partners

To be considered for this opportunity, you must have the following:

Minimum of a bachelor’s degree and 8+ years of pharmacovigilance experience with focus on Aggregate Reporting

Experience with CA Inspections (PV and GCP)

Strong knowledge of current regulatory guidelines and regulations for FDA, EU and ROW

Medical writing experience with regulatory documentation

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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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually) $151,800.00 - $247,800.00

R31681

Remote/Remotely/Tele/Telecommute/From home