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Dyne Tx
Waltham, MA, United States
Our commitment to people with muscle diseases is our greatest strength Senior Director, Drug Safety and Pharmacovigilance Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCE platform, Dyne is develop
Job Source: Dyne TxBioSpace, Inc.
Waltham, MA, United States
Job Details Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in deliv
Job Source: BioSpace, Inc.Intellia Therapeutics, Inc.
Cambridge, MA, United States
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determin
Job Source: Intellia Therapeutics, Inc.Xenon Pharmaceuticals Inc.
Boston, MA, United States
Director, Pharmacovigilance and Drug Safety (Operations & Compliance) Boston, MA, USA Req #265 Monday, May 6, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people livi
Job Source: Xenon Pharmaceuticals Inc.Scorpion Therapeutics, Inc.
Boston, MA, United States
Position Overview: Scorpion Therapeutics is seeking a highly experienced and motivated Senior Manager or Associate Director to join our Drug Safety and Pharmacovigilance team. The Senior Manager or Associate Director will be responsible for overseeing external service provider/s (ESPs) performing drug safety and pharmacovigilance activities across
Job Source: Scorpion Therapeutics, Inc.Scorpion Therapeutics
Boston, MA, United States
Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and da
Job Source: Scorpion TherapeuticsScholar Rock, Inc.
Cambridge, MA, United States
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structur
Job Source: Scholar Rock, Inc.Scholar Rock
Cambridge, MA, United States
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structur
Job Source: Scholar RockBoston, MA, United States
The Senior Director, Drug Safety and Pharmacovigilance is responsible for leading safety surveillance and ensuring compliance with legal and regulatory requirements for pharmacovigilance, signal management, and risk management.
- MD degree and board certification preferred
- First in Human-Post Marketing experience
- 7+ years of experience as a safety physician in the industry
- Expertise in drug safety leadership
- Proficiency in safety data visualization tools
- Excellent communication and presentation skills
- Experience in authoring safety reports
- Knowledge of regulatory guidelines (FDA, EMA, GCP/GVP/ICH)
- Understanding of observational studies and statistical methods
- Exceptional interpersonal skills
- Ability to present recommendations effectively
- Application of pharmacology, chemistry, and toxicology*
- Capability to thrive in a fast-paced environment
- Boston-based- onsite 3 days a week requirement
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Email Alert for Senior Director, Drug Safety and Pharmacovigilance jobs in Boston, MA, United States
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