- 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 fastpaced environment
- Bostonbased onsite 3 days a week requirement
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Pharmacovigilance/safety Associate
4 days ago
Cardiovascular Clinical Studies Boston, United StatesPharmacovigilance/Safety Associate · Responsibilities of the Pharmacovigilance Associate include but are not limited to: · - Review of medical records for serious adverse event reporting · - Writing clinical narratives and FDA MedWatch form 3500 (if applicable) · - Entering data ...
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HireMinds Boston, MA, United StatesDirector/Sr. Director, Pharmacovigilance, Vaccine Safety · Boston, MA · Our client is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. The ideal candidate for this role will oversee signal and PV life-cycle management and will ...
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ONO PHARMA USA Cambridge, United StatesThis is a Senior Manager level role that oversees the effective delivery of and continued evolution of Pharmacovigilance (PV) activities related to organization's clinical development programs. · Develops and designs pharmacovigilance processes and procedures to ensure complianc ...
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BioSpace Cambridge, United StatesJob Details · 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 a ...
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Intellia Therapeutics Cambridge, United StatesWhy 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 strong ...
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Intellia Therapeutics Cambridge, United States Full timeWhy 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 strong ...
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Stratacuity Cambridge, United StatesSenior Drug Safety Specialist, Pharmacovigilance Records & Compliance Location: Cambridge, MA (Onsite) Science: Small Molecule Therapeutic Area: Oncology Job Overview: In this role, you will be a key contributor to drug safety activities, focusing on records management and compli ...
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Morphic Holding, Inc. Waltham, United States· About Morphic Therapeutic · Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaborati ...
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Dyne Therapeutics, Inc. Waltham, United StatesCompany 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 thera ...
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BioSpace Waltham, United StatesJob 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 FORCETM platform, Dyne is developing modern olig ...
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Dyne Therapeutics Waltham, United States Full timeCompany 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 FORCETM platform, Dyne is developing modern oligonucleotide the ...
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MURAL ONCOLOGY PLC Waltham, United StatesThe Mural team brings together oncology expertise and passion to make an impact on patients' lives. We are seeking a highly motivated individual to join our team. · Overview · The Executive Medical Director serves as the functional head of DSPV, and is accountable for the managem ...
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Alkermes Waltham, United StatesOverview: · The Executive Medical Director serves as a senior member of the DSPV leadership team, accountable for the management, mentoring and development of assigned benefit-risk management staff as well as serving as a global safety officer for assigned investigational and/or ...
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Sanofi Group Bridgewater, United StatesHead of Pharmacoepidemiology Vaccines, Patient Safety Pharmacovigilance (PSPV), provides scientific and strategic leadership in epidemiology to demonstrate vaccines safety. The Head is accountable for defining the overall strategy, the design and method, and the execution/operati ...
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Dragonfly Therapeutics Waltham, MA, United StatesDragonfly Therapeutics seeks a Director/Sr. Director/Executive Director of Pharmacovigilence & Drug Safety to support product safety and compliance. The successful candidate will report to the VP of Pharmacoviglence and be responsible for managing drug safety data to support sign ...
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Stratacuity Waltham, MA, United StatesSr. Director/Executive Director PV and Drug Safety Location: Waltham, MA (Onsite) Therapeutic Area: Immuno-Oncology Job Overview: This role will be responsible for managing drug safety data, authoring safety documents, organizing meetings, collaborating with cross-functional team ...
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Apex Systems Waltham, MA, United StatesDirector/ Senior Director/ Executive Director of Pharmacovigilance and Drug Safety · Sr. Director/Executive Director PV and Drug Safety · Location: Waltham, MA (Onsite) · Therapeutic Area: Immuno-Oncology · Job Overview: This role will be responsible for managing drug safet ...
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Drug Safety Associate
1 day ago
Talent Groups Waltham, United States3-5 years of experience in drug safety, pharmacovigilance, or clinical safety within the pharmaceutical or biotechnology industry. · - Knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH). · - Strong analytical skills with the ability to critical ...
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Meet Boston, MA, United StatesCompetitiveBoston, United StatesPermanentAn exciting opportunity with a pioneering pharmaceutical company dedicated to advancing healthcare through innovative drug development within Neurology. With a focus on breakthrough therapies, striving to improve the lives of patients worl ...
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GPS Global Safety Physician
5 hours ago
Ironwood Pharmaceuticals Boston, United States Full timeIronwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription ...
Senior Director, Drug Safety and Pharmacovigilance - Boston, MA, United States - The Elle Group
Description
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.
Senior Director, Drug Safety and Pharmacovigilance professionals in Boston
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Bryan Paul
Sr Cybersecurity Professional
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Bob Sansone
Special Education Teacher