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Minimum requirement: 7+ years’ experience in in drug safety/pharmacovigilance physician in clinical development. Lead the development of safety risk management plans, safety components of IND/NDA/MAA filings, annual safety reports.
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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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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.
$150ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Skills and/or behavioral assessment Personal interview Verification of education and experience (including certifications and licenses) Criminal Background Check (a criminal conviction is not an automatic bar to employment) Medical examination including a drug and alcohol screening (for safety sensitive positions) Review of a current motor vehicle report.
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You will be able to develop your knowledge and skills by working together with experts and leaders in Oncology R&D, safety science, pharmacology, toxicology, drug discovery and development, imaging, pathology, and translational science.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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The role may span multiple oncology assets and the entire life cycle of drug development and peri-/post-submission, from the early to late phases of development, and include delivery through one or more in-house, outsourced, and alliance delivery models.
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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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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.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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This role will have the medical safety expertise to perform obligatory safety functions with oversight from global drug safety lead. Oncology experience and clinical development experience strongly preferred.
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Strong knowledge and agility in study design and data interpretation and in the integration of Toxicology studies in the drug progression paradigm, as well as in the incorporation of safety endpoints in pharmacology studies.
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Demonstrated 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 and global safety regulations highly preferred.
$186,000 - $322,000 a yearFull-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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5+ years of drug safety/pharmacovigilance experience or in an environment with a function similar to that of Pharmacovigilance. Provides strategic direction to the Safety Scientists and leads the review of the overall benefit/risk profile of marketed products and compounds in development at specified intervals according to regulatory requirements and SOPs.
$155,000 - $195,000RemoteExpandApply NowActive JobUpdated 1 month ago
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