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safety & pharmacovigilence specialist
2 weeks ago
Beacon Hill Cambridge, United StatesSAFETY & PHARMACOVIGILENCE SPECIALIST · Candidate must be currently located in the DMV area · 6 month temp to hire · Location - Cambridge, MA (hybrid schedule) · Medical experience and drug safety experience is Required · Pharm D, Nursing MD or DO · RESPONSIBILITIES · • perform v ...
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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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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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safety & pharmacovigilence specialist
2 weeks ago
Beacon Hill Cambridge, United StatesSAFETY & PHARMACOVIGILENCE SPECIALIST · Candidate must be currently located in the DMV area · 6 month temp to hire · Location - Cambridge, MA (hybrid schedule) · Medical experience and drug safety experience is Required · Pharm D, Nursing MD or DO · RESPONSIBILITIES · • perform v ...
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Morphic Therapeutic Waltham, United StatesAbout 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 collaboration ...
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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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Pharmacovigilance/safety Associate
3 weeks 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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Intellia Therapeutics, Inc. 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 strongly t ...
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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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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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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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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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Intellia Therapeutics Cambridge, MA, 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 strongly t ...
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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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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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Vice President, Pharmacovigilance
2 weeks ago
Viridian Therapeutics Inc. Waltham, United States· At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team's expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therap ...
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Ardelyx, Inc. Waltham, United StatesArdelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA(tenapanor) and XPHOZAH (tenapanor), as well as earl ...
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Pharmacovigilance Operations Lead
1 week ago
Tetraphase Pharmaceuticals Waltham, United StatesPosition Title · Pharmacovigilance Operations Lead (contractor) · Department · Pharmacovigilance · Reports to · Head of Pharmacovigilance · Location · Hybrid · Details · Exempt · Direct Reports · none · Company Overview: · Innoviva Specialty Therapeutics is dedicated to bringing ...
Executive Medical Director, Drug Safety and Pharmacovigilance - Waltham, United States - Alkermes
Description
Overview:
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 marketed products.
Reporting to the Head of DSPV, the Executive Medical Director will also serve in a visible role in providing safety leadership and advisement in several company-wide forums and initiatives.
The successful candidate will have demonstrated prior career success as a product safety physician and managing/ developing individuals and highly effective teams.
This leader will be expected to roll-up their sleeves and help do the work in addition to managing direct reports.
Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively and to be able to effectively communicate with varied stakeholders both verbally and in writing.
The individual who assumes this position will interact with multiple levels of management within Alkermes, external stakeholders in the medical community, as well with global regulatory authorities.
