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As an Associate Digital Product Manager in IT & Digital, you will have a critical role in overseeing the product strategy, development/implementation and management of technology products in different focus areas in Global Drug Safety and Pharmacovigilance.
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Highly-developed scientific and analytical knowledge base and an excellent understanding of good pharmacovigilance practices and current regulations within drug safety. Thorough understanding of U.S. pharmacovigilance regulations, GCP and International Conference on Harmonization (ICH) guidelines.
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This individual will ensure timely, consistent, and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and best practice, scalable, standard operating procedures (SOPs.
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Strong knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulations. The position may be filled at the Associate Director or Senior Manager level and will report to the Pharmacovigilance Risk Management Lead in Waltham, MA.
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Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.
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Director of Pharmacovigilance & Regulatory Affairs. There is a Pharmacovigilance Medical Director and a small US-based regulatory team and in-country contract resources in international regions that will report to the VP.
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As the Director, Pharmacovigilance Operations you will report to the Head of PV and Safety and be involved in all related operational activities of product safety surveillance and ensure the safety of product development.
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Strong previous Pharmacovigilance/Drug Safetyexperience is required. Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Preference will be given to those with a deep knowledge of Oncology or Rare Disease studies.
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Takeda Development Center Americas, Inc. is seeking a Senior Manager, Pharmacovigilance (PV) Business Partner Relations in Lexington, MA with the following requirements: Bachelor's degree in Clinical, Regulatory Affairs, Pharmacy, or related field or foreign academic equivalent plus 5 years of related experience.
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10+ years of experience in drug safety/pharmacovigilance in global clinical trial setting (title will be commensurate with the candidate's HCP background and industry experience) Expert knowledge of FDA and EU safety regulations, ICH Guidelines, Good Pharmacovigilance Practice (GVP) and other applicable safety and regulatory guidance documents.
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Kyowa Kirin (KKNA)is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology, and CNS/movement disorders.
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MD with 10+ years of experience in drug development and drug safety/pharmacovigilance, with specific expertise in clinical oncology, immunology, or genetics. Prior experience in gene therapy products or biologics, demonstrating the ability to navigate the unique challenges of pharmacovigilance in these areas.
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The Director, Pharmacovigilance Systems and Data Management (Dir, PV Systems & DM) will be responsible for overseeing various aspects of PV systems and data management, as it pertains to Safety database configuration, data integrity, regulatory reporting, license partner exchange, aggregate report and ad-hoc report generation, signal detection and management tool, and the safety service provider(s.
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The Director of Drug Safety, working under the guidance of an Executive Director, or the Head of Drug safety & Pharmacovigilance, is responsible for the clinical safety strategy for assigned projects and products, provides drug safety expertise and guidance to Clinical Development, Safety Oversight Committee (SOC) and the Clinical Project Teams, and drives proactive implementation of risk management initiatives in accordance with global regulatory requirements.
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Director, Pharmacovigilance 2025263. Experience with MedDRA coding, safety databases, and clinical trial databases. Job Overview: This director will lead and oversee safety and benefit-risk management for assigned products, working closely with the Global Safety Physician and Medical Risk Management team, serving as a subject matter expert on product safety information and global safety regulations.
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Title: pharmacovigilance Company: Kyowa Kirin
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