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Senior Drug Safety Specialist, Pharmacovigilance Records & Compliance 2022831. Bachelors degree in nursing, pharmacy, or a related healthcare field and have at least 2 years of experience in drug safety, pharmacovigilance, or a similar role within the pharmaceutical industry.
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At least 10 years relevant clinical drug safety/pharmacovigilance experience within the pharmaceutical or biotech industry, including 3+ years vendor oversight experience, required. You will serve as the primary pharmacovigilance lead on study teams and liaise with cross functional team members, as well as external vendors and services providers; performing drug safety study start-up, maintenance, and close-out activities.
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Direct the planning and implementation of process development, scale-up, technology transfer, and validation efforts in drug substance manufacturing, ensuring strategic alignment and operational excellence.
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Job Title: Senior Drug Safety Specialist. · Reporting to the Associate Director, Drug Safety and Pharmacovigilance Compliance and Operations, you will play a pivotal role in drug safety activities, supporting records management and compliance across the clinical development and marketing programs.
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Deliver: Spearhead drug discovery projects, Design, execute, analyze, and interpret in vitro and in vivo experiments. As a Senior Scientist, you will work within the RNA Medicine team to develop a novel nucleic acid drug development platform.
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Solid clinical experience from direct patient care (clinical experience and/or board certification in Oncology, Immunology, Genetics desired) and 10+ years of experience in drug development and in drug safety/pharmacovigilance required.
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With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody-drug Conjugates, Cell Therapy, and Epigenetics) to help address unmet clinical needs in a host of cancers, we are motivated by a dedication to the scientific discovery and collaboration that will one day help eliminate cancer as a cause of death.
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10+ years of experience in drug safety/pharmacovigilance within global clinical trial settings, with expertise in FDA, EU, ICH regulations, and Good Pharmacovigilance Practice guidelines. Sr. Director/Executive Director PV and Drug Safety 2020394 Location: Waltham, MA (Onsite) Therapeutic Area: Immuno-Oncology Job Overview: This role will be responsible for managing drug safety data, authoring safety documents, organizing meetings, collaborating with cross-functional teams, ensuring compliance with global drug safety regulations, and providing vendor oversight.
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A minimum of 10 years of related pharmaceutical or biotechnology industry experience in clinical pharmacology, population PK, PK-PD modeling, DMPK, and/or pharmacometrics and a proven track record advancing programs through the drug development process, from discovery through IND to registration, informing data driven decisions on dose and schedule, making tough judgement calls where needed.
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Oversee the design and protocol writing of clinical pharmacology studies (e.g., food effect, human ADME, drug-drug interactions, QTc, and hepatic/renal impairment) Lead or Co-lead all quantitative pharmacology activities to support both regulatory filings and internal decision-making (e.g., Exposure-Response, QTc prolongation risk assessment, population PK/PD analysis) by working closely with internal colleagues (i.e. DMPK, toxicology, biology, clinical, statistics) and external vendors to advance programs from Phase I to late-stage development.
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Located in Boston, Jnana brings together scientific leaders in small molecule drug discovery and development, a highly experienced management team, and the backing of leading life science investors Bain Capital Life Sciences, RA Capital Management, Polaris Partners, Versant Ventures, Avalon Ventures, Pfizer Ventures, and AbbVie Ventures.
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Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 10-12+ years of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments.
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We are a driving force behind drug discovery, and we are now eagerly searching for an exceptional computational scientist like you to join our ranks. Work at the intersection of experimental and groundbreaking digital technologies, with a particular emphasis on expertise in machine learning and artificial intelligence (AI) as applied to small molecule drug discovery.
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Experienced in all phases of biologics, gene therapy, and/or cell therapy drug development. QC, Supplier Quality), you will provide Quality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines at GTMF and/or contract manufacturing organizations (CMO.
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The Director, CMC QA will report to the Executive Director of CMC QA and be responsible for maintaining strategic responsibility over QA Operations, developing and implementing Ultragenyx CMC Quality approach for assigned Gene Therapy programs, and working with colleagues to improve processes utilized to ensure product quality.
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