VP, Head of Safety and Pharmacovigilance
2 weeks ago
Our client is developing best-in-class therapeutics to treat and potentially cure cancer patients. Please read the information in this job post thoroughly to understand exactly what is expected of potential candidates. This role is pivotal in ensuring that our client remains a leader in patient safety and pharmacovigilance, fostering a culture where safety is integrated into every aspect of our drug development process. Reporting directly to the Chief Medical Officer (CMO), you will be leading and building out the client’s PV and risk management function. This includes being responsible for the strategic oversight and execution of all safety and pharmacovigilance activities, ensuring compliance with global regulatory standards. As the VP, Head of Safety and Pharmacovigilance, you will lead the client’s efforts in ensuring the safety of our investigational products. This involves providing strategic medical oversight, managing safety data, and guiding cross-functional collaboration to integrate safety into all phases of our product lifecycle. As our client is building out it’s PV department anew, you will be responsible for creating and building the Safety and Risk Management function. Your role will include interacting with regulatory authorities, leading the pharmacovigilance team, and overseeing the activities of external safety service providers. Key Responsibilities Lead and build our client's PV and Risk Management function Establish and maintain a safety and pharmacovigilance infrastructure that prioritizes “safety by design” in all development activities. Lead all pharmacovigilance and risk management activities for our client's products, including safety surveillance, signal detection, and risk-benefit assessments. Serve as the primary contact for safety-related issues, including regulatory authority interactions and safety service provider management. Provide strategic safety insights to the CMO and Executive Leadership Team, particularly regarding the risk-benefit profile of company products. Oversee the preparation and review of safety documents, including DSURs, safety reports, and clinical development documentation. Ensure compliance with global safety regulations and guidelines, and lead responses to safety-related inquiries from regulatory authorities. Manage the pharmacovigilance budget and resources, including both internal teams and external contractors. Drive continuous improvement in pharmacovigilance practices, ensuring readiness for regulatory inspections and audits. Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Quality, to integrate safety considerations into company strategy. Represent our client externally, building relationships with industry leaders and vendors to enhance our safety and pharmacovigilance capabilities. Key Requirements M.D., D.O., or M.B.B.S. required. Minimum of 10 years of global experience in drug safety within the biotechnology or pharmaceutical industry. In-depth knowledge of FDA safety regulations, ICH Guidelines, EU GVP, and other global safety regulations. Deep understanding of risks and risk mitigation steps related to safety signals and pharmacovigilance Expert knowledge of safety database applications (e.g., ARGUS, ARISg) and safety signal detection. Strong leadership skills with the ability to mentor teams and lead cross-functional initiatives. xrczosw Excellent written, verbal, and presentation skills, with the ability to influence senior leadership and external stakeholders.
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VP of Safety
3 weeks ago
Boston, MA, United States Klein Hersh International Full timeA leading biotechnology firm in Boston seeks a VP, Head of Safety and Pharmacovigilance. Please read the information in this job post thoroughly to understand exactly what is expected of potential candidates. The role involves overseeing safety and pharmacovigilance activities, ensuring compliance with regulations, and leading a team to enhance product...
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Head of Drug Safety
2 weeks ago
Boston, MA, United States Klein Hersh International Full timeOur client is a clinical-stage biopharmaceutical company focused on building the future of oncological therapy to improve patient outcomes. If you think you are the right match for the following opportunity, apply after reading the complete description. The Head of Drug Safety and Pharmacovigilance (PV), is responsible for the leadership and oversight of...
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Boston, MA, United States Tubulis GmbH Full timeGlobal Head of Pharmacovigilance and Safety Science Permanent employee,Full-time· Boston (USA) Remember to check your CV before applying Also, ensure you read through all the requirements related to this role. Be part of our team The Global Head of Pharmacovigilance and Safety Science is a strategic leadership role responsible for medical, strategic, and...
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Chief Safety
2 weeks ago
Boston, MA, United States Klein Hersh International Full timeA clinical-stage biopharmaceutical company is seeking a Head of Drug Safety and Pharmacovigilance in Boston, MA. Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below. The ideal candidate will have over 15 years of experience, including leadership roles in safety for biopharmaceuticals,...
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Boston, United States Tubulis GmbH Full timeGlobal Head of Pharmacovigilance and Safety Science Join to apply for the Global Head of Pharmacovigilance and Safety Science role at Tubulis GmbH. Take your career to the next level with Tubulis, a clinical stage biotech company that generates uniquely matched antibody‑drug conjugates (ADCs) with superior biophysical properties. We recently closed a...
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Global Head of Pharmacovigilance
4 hours ago
Boston, United States Tubulis GmbH Full timeA fast-growing biotech firm in Boston seeks a Global Head of Pharmacovigilance and Safety Science. This executive role involves developing drug safety strategies and ensuring compliance in oncology drug products. The ideal candidate has an MD and extensive experience in drug safety, especially with antibody-drug conjugates. Responsibilities include...
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Vice President, Safety and Pharmacovigilance
58 minutes ago
Boston, United States Tango Therapeutics Full timeVice President, Safety and Pharmacovigilance Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop...
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Vice President, Safety and Pharmacovigilance
3 weeks ago
Boston, United States Tango Therapeutics Full timeCompany Overview Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at...
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Vice President, Safety and Pharmacovigilance
6 days ago
Boston, Massachusetts, United States Tango Therapeutics Full time $311,200 - $466,800Company OverviewTango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at...
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Vice President, Safety and Pharmacovigilance
5 hours ago
Boston, Massachusetts, United States Tango Therapeutics Full timeCompany OverviewTango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at...
