Executive/Senior Medical Director, Pharmacovigilance
2 weeks ago
CompetitiveBoston, 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 worldwide.Position Overview:This innovative organization is looking to bring on a highly experienced and dynamic Senior Medical Director to lead our Pharmacovigilance & Drug Safety team. This pivotal role will involve overseeing the safety profile of our pharmaceutical products throughout their lifecycle, ensuring compliance with regulatory standards, and driving continuous improvement in safety monitoring processes.Responsibilities:Provide strategic leadership and direction for pharmacovigilance and drug safety activities.Develop and implement pharmacovigilance processes and systems to ensure the timely and accurate assessment of safety data.Collaborate cross-functionally with clinical development, regulatory affairs, and other departments to integrate safety considerations into product development plans.Lead the evaluation of safety signals, conduct risk assessments, and implement risk management strategies.Oversee the preparation and submission of safety reports to regulatory authorities in compliance with regulatory requirements.Serve as the primary point of contact for safety-related inquiries from regulatory agencies, healthcare professionals, and internal stakeholders.Mentor and develop team members, fostering a culture of excellence and continuous learning within the pharmacovigilance department.Qualifications:Medical degree (MD) or equivalent advanced degree in life sciences.Board certification or equivalent experience in pharmacovigilance and drug safety.Extensive experience in pharmacovigilance within the pharmaceutical industry, with a strong understanding of global regulatory requirements.Proven leadership skills with the ability to inspire and motivate teams.Excellent communication and interpersonal skills, with the ability to collaborate effectively across functional areas and with external partners.Strong analytical and problem-solving abilities, with a keen attention to detail.Demonstrated ability to drive results in a fast-paced and dynamic environment.
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Boston, United States The Elle Group Full timeThe 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...
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Boston, United States HireMinds Full timeDirector/Sr. Director, Pharmacovigilance, Vaccine SafetyBoston, MAOur 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 be involved in a broad variety of PV and clinical safety activities.This is a full-time...
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Boston, United States HireMinds Full timeDirector/Sr. Director, Pharmacovigilance, Vaccine SafetyBoston, MAOur 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 be involved in a broad variety of PV and clinical safety activities.This is a full-time...
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Director, Pharmacovigilance Scientist
2 weeks ago
Boston, United States Verve Therapeutics Inc Full timeThe Position Verve is seeking a director level pharmacovigilance (PV) Scientist. This is an individual contributor role and an exciting opportunity to be on the ground floor of a developing PV department working on cutting-edge therapies. This role will provide day-to-day oversight of safety monitoring activities and safety operations as well as management...
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Director, Head Pharmacovigilance, Vaccine Safety
2 weeks ago
Boston, United States HireMinds LLC Full timeOur vaccine client base in Boston, MA is looking to add a Director, Head Pharmacovigilance, Vaccine Safety to their team (CONTRACT/REMOTE)! The ideal candidate will oversee signal and PV life-cycle management and will be involved in a broad variety of PV and clinical safety activities. This contract role will be full-time/40 hours/week and may have the...
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Pharmacovigilance/safety Associate
1 month ago
Boston, United States Cardiovascular Clinical Studies Full timePharmacovigilance/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 into Safety Database - Working with other safety personnel in cross checking cases as...
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Senior Medical Director, Global Drug Safety
2 weeks ago
Boston, United States Alexion Pharmaceuticals, Inc. Full timeThis is what you will do: The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution...
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Vice President, Head of Safety
2 days ago
Boston, United States Astria Therapeutics, Inc. Full timePosition Overview:Astria is seeking an innovative and collaborative individual who will play a pivotal role in fostering a culture of safety within the company ensuring that Astria remains at the forefront of patient safety and pharmacovigilance. The individual will be responsible for the strategic implementation, execution, and management of...
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Vice President, Head of Safety
6 days ago
Boston, United States Astria Therapeutics, Inc. Full timePosition Overview:Astria is seeking an innovative and collaborative individual who will play a pivotal role in fostering a culture of safety within the company ensuring that Astria remains at the forefront of patient safety and pharmacovigilance. The individual will be responsible for the strategic implementation, execution, and management of...
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Vice President, Head of Safety
5 days ago
Boston, United States Astria Therapeutics, Inc. Full timePosition Overview:Astria is seeking an innovative and collaborative individual who will play a pivotal role in fostering a culture of safety within the company ensuring that Astria remains at the forefront of patient safety and pharmacovigilance. The individual will be responsible for the strategic implementation, execution, and management of...
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Director, Pharmacovigilance
2 weeks ago
Boston, United States Ironwood Pharmaceuticals, Inc. 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 market leader for adults with irritable bowel syndrome with constipation or...
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Director, Pharmacovigilance
1 month ago
Boston, United States Ironwood Pharmaceuticals 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 market leader for adults with irritable bowel syndrome with constipation or...
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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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Senior Medical Director, Global Drug Safety
2 weeks ago
Boston, United States Alexion Pharmaceuticals, Inc. Full timeThis is what you will do: The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution...
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Medical Director, Clinical Safety Physician
4 days ago
Boston, United States Klein Hersh Full timeCurrently our client employees have the opportunity to directly impact global health through COVID-19 vaccine development and post-authorization global administration, and the portfolio is poised to deliver in other important therapeutic areas with unmet medical need. The Clinical Safety group ensures the safety use of our vaccines and therapeutics through...
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Executive Director
4 days ago
Boston, United States Joseph Nee South Boston Collaborative Center Full time**Description**: The Joseph Nee South Boston Collaborative Center is a community-based Non-Profit with a mission to create a safe and welcoming environment providing substance use and mental health counseling services in an outpatient setting serving the Greater Boston Community. The Joseph Nee South Boston Collaborative Center goal is to improve and enhance...
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Executive Medical Director
2 days ago
Boston, United States RBW Consulting Full timeA clinical stage precision oncology business in Boston, MA requires an Executive Medical Director lead a team of Medical Directors in the advancement of therapies for solid tumors based on their proprietary CRISPR-based platform.Responsibilities:Establish clinical development plans and deliver on program milestones, in partnership with clinical...
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Executive Medical Director
7 days ago
Boston, United States RBW Consulting Full timeA clinical stage precision oncology business in Boston, MA requires an Executive Medical Director lead a team of Medical Directors in the advancement of therapies for solid tumors based on their proprietary CRISPR-based platform.Responsibilities:Establish clinical development plans and deliver on program milestones, in partnership with clinical...
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Executive Medical Director
7 days ago
Boston, United States RBW Consulting Full timeA clinical stage precision oncology business in Boston, MA requires an Executive Medical Director lead a team of Medical Directors in the advancement of therapies for solid tumors based on their proprietary CRISPR-based platform.Responsibilities:Establish clinical development plans and deliver on program milestones, in partnership with clinical...
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Boston, MA, United States Genentech Full timeThe PositionRoche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. Due to new projects in the cardiovascular therapeutic...