Temp Associate Director, Aggregate Reporting, GPS

Pay Range: $101.43 - $126.86/hr

Remote Role (US Only)

12 Month Contract 

This position 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.

A typical day may include the following:

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

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

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

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

This role may be for you if have:

Extensive knowledge of US, ICH, EU PV and GCP/GVP regulations

Experience with CA Inspections (PV and GCP).

Experience working with Alliance Partners

Medical writing experience with regulatory documentation

To be considered for this opportunity, you are expected to have a minimum of a bachelor’s degree, Life Sciences preferred. Minimum 7+ years of pharmacovigilance experience with focus on authoring and management of Aggregate Reporting.

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation