Associate Director, Pharmacovigilance Quality Assurance
Alnylam Pharmaceuticals | |
United States, Massachusetts, Cambridge | |
675 West Kendall Street (Show on map) | |
Dec 21, 2024 | |
This role is considered Hybrid. Responsibilities: This role is a member of the GVP QA team providing Quality oversight of Alnylam's global post-marketing pharmacovigilance system, full application of EMA Good Pharmacovigilance Practices (GVP) Modules, and implementation of other worldwide PV regulations, and application of Good Pharmacoepidemiology Practice (GPP) and Good Post-marketing Study Practice (GPSP). This includes support of the development and execution of the GVP audit program as well as contributing to Alnylam's Inspection activities. The Associate Director PV QA will deputize for Director Global PV QA as needed. This position reports to the Director, Global PV Quality Assurance and frequently interacts with external parties, and cross-functional teams. Interactions will also be with cross-QA management and cross-EA management as needed. Summary of Key Responsibilities: Associate Director, PV QA supports all the GVP QA responsibilities as listed below. Different members of the team will have particular focus areas. The Associate Director will lead specific activities and support the more junior members of team:
Requirements and skills
About Alnylam:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality. Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law. > |