Alnylam Pharmaceuticals
Associate Director, Patient Safety & Risk Mgmnt (Finance)
Associate Director, PV Science
Overview
Alnylam is the world's leading RNA interference (RNAi) company.
Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with two approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.
Headquartered in Cambridge, Mass., Alnylam employs over 1,400 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2020 and Science Magazine's #1 Top Employer in 2019. Please visit www.alnylam.com for more information.
The Associate Director PV Science works closely with the Director PV Science as well as the Senior Director/Executive Director of Global Patient Safety & Risk Management (GPSRM) to provide internal safety representation to the development teams and medical affairs colleagues, conduct review of partner scientific and medical deliverables, and conduct activities associated with structured benefit risk assessment of assigned drugs. This role contributes to the safety and benefit-risk evaluations for the developmental and marketed products, the management of potential safety issues, evaluation of safety signals, and other activities such as facilitating of responses to regulatory inquiries with regard to safety topics.
Summary of Key Responsibilities
Clinical Trial Safety:
Requirements/Qualifications:
Education: Degree in a medical or healthcare related discipline (PharmD, RN), or high qualification relevant to scientific or business discipline.
In depth knowledge of global clinical and post marketing safety regulations, guidances, and reporting processes
Experience: A minimum of seven to ten years in the pharmaceutical industry with experience in Global Patient Safety & Risk Management/pharmacovigilance. Previous experience in managing Global Patient Safety & Risk Management personnel a plus. Specific experience in rare diseases therapeutic area at a global level is an advantage.
Competencies:
Supervision: Position will report to Director, PV Science, Medical Safety and Risk Management. Individual is expected to work independently with support from management and colleagues in Global Patient Safety & Risk Management department.
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.