Drug Safety/Pharmacovigilance
3 weeks ago
Experience processing Oncology cases
Have demonstrated knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance related to pharmacovigilance and Good Clinical Practices
Ability to make clinical decisions and formulate appropriate queries based on sound medical knowledge
Competence with commercial safety application databases such as Clintrace, ArisG or Argus. Knowledge of clinical trial database (e.g., Trailmaster) is a plus
Ability to work effectively as an individual contributor and as project team safety representative
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Waltham, United States Morphic Holding, Inc. Full timeDescription 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 collaboration with Schrödinger, Morphic is advancing its pipeline and discovery...
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Waltham, United States BioSpace, Inc. Full timeJob 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 delivery to...
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Waltham, United States BioSpace Full timeJob DetailsCompany 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 delivery to...
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Waltham, United States Dyne Therapeutics 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 FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...
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Waltham, Massachusetts, United States Dyne Therapeutics 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 therapeutics that are designed to overcome limitations in delivery to muscle tissue....
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Waltham, United States MURAL ONCOLOGY PLC Full timeThe 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 management, mentoring and development of assigned benefit-risk management staff as well...
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Hybrid Drug Safety Specialist
2 weeks ago
Waltham, United States Staffmark Group Full timeHybrid- 3 days minimum will be onsite. The Drug Safety Specialist will have primary responsibility for the following: Case Processing (CT/ PM) - 50% Responsible for the processing adverse event reports that include but not limited to the receipt, evaluation, reviewing and reporting of adverse event information for marketed and investigational products in...
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Medical Director, Pharmacovigilance
2 days ago
Waltham, United States Deciphera Pharmaceuticals Full timeJob Description Increase your chances of an interview by reading the following overview of this role before making an application.We are seeking a Medical Director. This position will report to the Senior Medical Director of Pharmacovigilance and will be located in the Waltham office.The Medical Director is responsible for global pharmacovigilance (PV) for...
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Medical Director, Pharmacovigilance
3 weeks ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob Description We are seeking a Medical Director. This position will report to the Senior Medical Director of Pharmacovigilance and will be located in the Waltham office. The Medical Director is responsible for global pharmacovigilance (PV) for marketed and/or investigational products, including review and analysis of safety data from post-marketing...
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Waltham, United States Deciphera Full timeCompany Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. Enabled...
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Waltham, United States Deciphera Pharmaceuticals Full timeJob DescriptionJob DescriptionCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of...
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Waltham, United States Deciphera Pharmaceuticals Full timeJob DescriptionJob DescriptionCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of...
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Drug Safety Specialist
2 weeks ago
Waltham, United States Queen Consulting Group, Inc. Full timeOur client is seeking a Drug Safety Specialist with clinical experience. The Drug Safety Specialist will have primary responsibility for the following: Case Processing (CT/ PM) - 50% Responsible for the processing adverse event reports that include b Safety Specialist, Drug, Specialist, Clinical, Processing, Product Development, Healthcare, Staffing
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Waltham, MA, United States Deciphera Pharmaceuticals Full timeCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.Enabled by...
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Waltham, United States Alkermes Full timeOverview: 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...
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Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob Description The Associate Director/Senior Manager, Pharmacovigilance and Risk Management, serves as a critical medical and data analytical role for the assigned investigational and/or marketed product(s). The successful candidate is expected to be equally effective working independently as well as collaboratively. She/he must possess knowledge and...
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Senior Manager, Pharmacovigilance Quality
3 weeks ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob Description The Senior Manager, Pharmacovigilance (PV) Quality encompasses a key leadership role in providing direction to the PV department and promote the spirit of proactive, continuous quality improvement in adverse event case management for all Deciphera Pharmaceuticals Clinical Trials, Extended Access Programs and post marketing (where...
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Waltham, United States AstraZeneca PLC Full timeJob Profile: Associate Director, Senior Patient Safety Scientist Location: Onsite w flexibility in Waltham MA At AstraZeneca, we work together to deliver innovative medicines to patients across global boundaries. We make an impact and find solutions to challenges. We do this with integrity, even in the most difficult situations, because we are committed to...
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SVP, Head of Clinical Development
4 weeks ago
Waltham, United States Dyne Therapeutics 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 FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...
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SVP, Head of Clinical Development
2 weeks ago
Waltham, United States BioSpace Full timeJob DetailsCompany 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 delivery to...