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Vice President, Drug Safety
5 days ago
Bicycle Therapeutics Limited Cambridge, United StatesCompany Description · Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides cons ...
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Medical Director, Drug Safety
2 weeks ago
Stratacuity Cambridge, United StatesMedical Director, Drug Safety & Pharmacovigilance Location: Cambridge MA (Onsite) Science/ Focus: CRISPR/Cas9 Therapeutic Area: Rare Disease Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a un ...
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Medical Director, Drug Safety
2 weeks ago
Biogen Cambridge, United StatesCompany Description · Job Description · About This Role · The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials ...
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Medical Director, Drug Safety
2 weeks ago
Biogen Idec Cambridge, United StatesCompany DescriptionJob Description · About This Role · The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, th ...
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Medical Director, Drug Safety
2 weeks ago
Biogen Idec Cambridge, United StatesCompany DescriptionJob Description · About This Role · The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, th ...
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Vice President, Drug Safety
2 days ago
Bicycle Therapeutics Cambridge, United StatesJob Description · Job DescriptionCompany Description · Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are ful ...
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Medical Director, Drug Safety
4 weeks ago
Apex Systems Cambridge, United StatesMedical Director, Drug Safety & Pharmacovigilance · Location:Cambridge MA (Onsite) · Science/ Focus:CRISPR/Cas9 · Therapeutic Area:Rare Disease · Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, provi ...
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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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Associate Medical Director, Drug Safety
2 weeks ago
Biogen Cambridge, United States Full timeJob Description · What you'll do: · The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, identification and ...
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Drug Safety Specialist
2 weeks ago
Beacon Hill Life Sciences - Boston Waltham, United StatesJob Description · Job DescriptionCase 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 accord ...
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Associate Medical Director, Drug Safety
2 weeks ago
Biogen Cambridge, United StatesCompany Description · Job Description · What you'll do: · The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials ...
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Medical Director, Drug Safety
3 weeks ago
Apex Systems Cambridge, United StatesJob#: · Job Description: · Medical Director, Drug Safety & Pharmacovigilance · Location: Cambridge MA (Onsite) · Science/ Focus: CRISPR/Cas9 · Therapeutic Area: Rare Disease · Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug d ...
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Associate Medical Director, Drug Safety
21 hours ago
Biogen Idec Cambridge, United StatesCompany DescriptionJob Description · What you'll do: · The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, i ...
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Medical Director, Drug Safety
2 weeks ago
Stratacuity Cambridge, United StatesLocation: Cambridge MA (Onsite) · Science/ Focus: CRISPR/Cas9 · Therapeutic Area: Rare Disease · Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize the implem ...
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Medical Director, Drug Safety
3 weeks ago
LeadingAge Cambridge, United StatesLocation: · Cambridge MA (Onsite) · Science/ Focus: · CRISPR/Cas9 · Therapeutic Area: · Rare Disease · Job Overview: · This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize t ...
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Medical Director, Drug Safety
2 weeks ago
Apex Systems Cambridge, United StatesMedical Director, Drug Safety & Pharmacovigilance Location:Cambridge MA (Onsite)Science/ Focus:CRISPR/Cas9Therapeutic Area:Rare Disease Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique ...
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Medical Director, Drug Safety
3 weeks ago
Biogen Cambridge, United StatesJob Description · Job DescriptionJob Description · About This Role · The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clin ...
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Medical Director, Drug Safety
3 weeks ago
Biogen Cambridge, United StatesJob Description · The following information aims to provide potential candidates with a better understanding of the requirements for this role. · About This Role · The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigationa ...
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Drug Safety Associate
3 weeks 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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Associate Medical Director, Drug Safety
6 days ago
Biogen Cambridge, United StatesJob Description · What you'll do: · The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, identification and i ...
Medical Director, Drug Safety - Cambridge, United States - Biogen
Description
Job DescriptionYou could be just the right applicant for this job Read all associated information and make sure to apply.
About This Role
The Medical Director, Drug Safety is responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification, and investigation of safety signals, management of benefit-risk profile for assigned compounds and products.
What You'll Do
Manage safety surveillance for assigned products and collaborate with PV scientists and other stakeholders
Conduct analyses of safety trial data.
Ensure adequacy of summarizing and handling of adverse events for investigational and/or marketed Biogen products including decisions on seriousness, expectedness, and causality.
Provide safety strategic leadership for clinical development programsIntegrate the safety scientific component to building a strategic framework for clinical development plans.
Develop and maintain relationships with counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, and Worldwide Medical.
Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timelines and timelines set by regulatory authorities.
You demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through the life cycle.
The individual who assumes this position will interact with multiple levels of management within Biogen, external stakeholders in the medical community as well with global regulatory authorities.
