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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.
ExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Position will lead as Deputy to Head of Safety and Pharmacovigilance Department with full oversight of Drug Safety Physicians team. Lead negotiations related to drug safety and risk management in pharmacovigilance agreements.
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Thorough understanding of the cross functional drug development processes (Clinical Operations, Biometrics, and Regulatory Affairs) and context applicable to safety surveillance activities required.
Full-timeRemoteExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Minimum requirement: 12+ years experience in in drug safety/pharmacovigilance in clinical development and post-marketing preferably in oncology. The Drug Safety & Pharmacovigilance (GDS&PV) Physician role is a safety expert medical role contributing to the global safety strategy and overall safety profile for the assigned Genmab products (mainly investigational) throughout their lifecycle.
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You will work together with other Drug Safety staff in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports, and communicating changes in the product risk profile to internal and external stakeholders supporting the Team Lead. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.
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Ensures compliance with global regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements. Develops, reviews and updates drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e. SAE data collection form, PADER template etc.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Collaborates with the Safety Physician to provide necessary information for the identification and investigation of potential safety signals and contribute to the development of risk management and pharmacovigilance plans.
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Assist the with the development of Safety Systems, in collaboration with other VPs, the GMs, and under the leadership of the VP, Safety. Support the development of presentation and instructional training to enhance the competencies of the assigned local Safety and Training Managers.
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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 Today - UpvoteDownvoteShare Job
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Extensive drug safety/pharmacovigilance experience within the pharmaceutical/biotechnology industry that includes development of innovative drugs, preferably in immuno-oncology/ inflammation therapeutic area(s.
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Demonstrated in-depth knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development.
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5 years of drug development/safety experience, including a product safety lead role. Drug development / safety experience across therapeutic areas, including Oncology.
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You'll work on a variety of products, both in clinical development and post-marketing drug safety. Our dedicated TA CRM Team is looking for an experienced Executive Director of Patient Safety Physician with expertise in cardiovascular, renal, metabolic, and/or respiratory diseases.
$250,000 - $420,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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In-depth knowledge of the cross-functional processes behind drug discovery and development, a strong understanding of partner needs, and the ability to develop integrated safety pharmacology-toxicology study plans.
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Actively leads the development and maintenance of the Company Core Safety Information (CCSI), proposes edits and manages approval of amendments. Develops and provides strategy, vision, and direction to Drug Safety Physician Team.
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drug development jobs Title: director safety in Crossville, Tennessee
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