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We are seeking a Director, Pharmacovigilance and Drug Safety (Operations & Compliance) to join our team. Provides oversight of case processing activities for the Xenon clinical development program and serves as safety data management subject matter expert (SME) on regulations and best practices for conventions and handling of safety data in Xenon’s global safety database (GSDB.
$210,000 - $239,500 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Minimum 12 years' experience as a safety physician with the biotechnology / pharmaceutical industry, leading drug safety & pharmacovigilance, including cross-functional team leadership for signal detection, evaluation, risk classification and management, and communication, for products across multiple stages of development.
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The Executive Director will guarantee that our product development and surveillance initiatives are conducted with paramount standards of patient safety, adhering to the rigorous demands of global regulatory authorities.
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Reporting to the Head of Safety, the Senior Medical Director, Drug Safety will lead pharmacovigilance activities including the analysis of safety data, identifying, detecting and investigating safety signals, evaluating and proactively managing risk, and providing medical safety review of Dianthus products.
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Our commitment to people with muscle diseasesis our greatest strengthSenior Director, Drug Safety and Pharmacovigilance. Role Summary:The Senior Director, Drug Safety and Pharmacovigilance will play a key leadership role in characterizing the safety profiles of Dyne products and mitigating and communicating their risks throughout the product lifecycle (from First-In-Human to post-marketing.
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Key success factors for the position include rare disease, cardiometabolic disease or immuno-oncology drug development experience, creativity, integrity in thought and action, team-centric mindset, integrative thinking, ability to influence decision-making, exceptional communication skills, the ability to inspire, and being a “hands-on doer.
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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.
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Collaborate with CMC, Program & Portfolio Management, Clinical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND filing, and clinical development of new small molecule drug entities.
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Our team is changing, and we are building a global team passionate about patient safety in the drug development process. The Hepatic Clinical Safety Knowledge Group (SKG) Lead manages a diverse range of activities related to monitoring, diagnosis, and mitigation of drug/biological-induced organ toxicity in a matrix environment.
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Playing a critical role within Scholar Rock, the Medical Director, Safety & Pharmacovigilance will be responsible for strategic medical leadership for global pharmacovigilance and risk management activities for Scholar Rock developmental candidates.
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Director, Pharmacovigilance and Drug Safety (Operations & Compliance) Experience in data outputs preparation for performing drug safety reports including periodic reports (DSUR, PBRER.
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Do you have 10+ years of experience in drug development and in drug safety/pharmacovigilance? If you are a strong problem-solver, agile with regulations and requirements for global safety surveillance & safety risk management in drug development and post-marketing settings, and enjoy cross-functional partnerships, this is the role for you.
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The Senior Director, Drug Safety and Pharmacovigilance will play a key leadership role in characterizing the safety profiles of Dyne products and mitigating and communicating their risks throughout the product lifecycle (from First-In-Human to post-marketing.
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This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize the implementation of safety surveillance for clinical trials, oversee the management of safety signals, take charge of cross-functional teams, and contribute to the development of regulatory safety deliverables.
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Leadership in cross-industry organizations (discipline-related or related to drug development). · Partner with the PCS Therapeutic Area Head for alignment with PCS Therapeutic Area Strategy Teams, PCS line functions and NIBR/Novartis Development project/program teams in managing the preparation and presentation of nonclinical safety data in internal and external documents (e.g. Investigator’s Brochure, IND, CTD, IMPD, Health Authority briefing books) and in negotiation with Health Authorities.
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drug development jobs Title: director safety in Watertown, MA
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