Stephanie Delahunt

Stephanie Delahunt has extensive experience in the field of pharmacovigilance and drug safety. Stephanie is currently working as the Senior Director and Head of Safety Operations at Agios Pharmaceuticals since October 2021. In this role, they are responsible for overseeing case processing, expedited reporting, and submission of safety reports.

Before joining Agios Pharmaceuticals, Stephanie worked at Takeda from January 2019 to March 2020 as the Global Drug Safety Director, Case Processing. Stephanie was accountable for ensuring the quality and timeliness of case processing activities by a PV vendor, in accordance with global regulations and Shire PV SOPs.

Prior to their role at Takeda, Stephanie worked at Shire from June 2016 to December 2018 as the Director and Head of Case Processing. Stephanie'sresponsibilities included overseeing outsourced pharmacovigilance activities, ensuring vendor compliance with regulatory reporting, and maintaining quality standards.

Stephanie also gained valuable experience at Biogen, where they worked from May 2013 to October 2016. Stephanie held various roles during their tenure, including Senior Manager, Case Processing Oversight and Senior Manager, Drug Safety. In these roles, they were responsible for managing case processing activities, ensuring compliance with regulatory requirements, and timely reporting of adverse event data.

Prior to their roles at Biogen, Stephanie worked at Boston Scientific as a Safety Program Manager and Safety Line Manager. Stephanie'sresponsibilities included managing teams, overseeing adverse event and medical device data processing, and ensuring safety plans of clinical trials were executed in accordance with corporate policies and procedures.

Stephanie started their career at the Reproductive Science Center of Boston as an Embryologist and gained experience in clinical data management at PAREXEL and Genzyme.

Overall, Stephanie Delahunt has a comprehensive work experience in pharmacovigilance, drug safety, case processing, and clinical data management.

Stephanie Delahunt holds a Bachelor's Degree in Animal Science from the University of New Hampshire. The specific duration of their education and their enrollment dates are not provided.