- Nuvalent, Inc. (Cambridge, MA)
- …development, and company building. The Role: Reporting to the Senior Medical Director, Pharmacovigilance , the Associate Director, Drug Safety and ... medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices,… more
- Formation Bio (New York, NY)
- …regulatory documents (meeting and briefing packages, regulatory filings); and pharmacovigilance documents (eg, annual reports/developmental safety update ... AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug ...AI tools Creates the timelines, in conjunction with the project team or relevant subteam, for completion of clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management experience in PV; required10 or more years of experience within Drug Safety / Pharmacovigilance experience, including both investigational and ... level handles escalated global CSPV case processing issue and handles project . This position prepares trainings, supports CAPA investigations, case review,… more
- ProPharma Group (Western Springs, IL)
- …in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance , medical information, and R&D technology, ProPharma offers an end-to-end ... consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. The Medical Promotional Review Consultant is responsible… more
- Sanofi Group (Morristown, NJ)
- …clinical development in at least one of the following areas: early development, safety , risk management, pharmacoepidemiology or pharmacovigilance + In depth and ... concepts in healthcare, human biology, data management and systems, epidemiology, pharmacology, pharmacovigilance , drug development and statistics + Drug … more
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. **Global Pharmacovigilance (PV) Senior Scientist** **What you will do** Let's do this. Let's ... this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for...guidance of GSO + Support activities related to new drug applications and other regulatory filings + Assist GSO… more
- Sumitomo Pharma (Lincoln, NE)
- …with minimal supervision. **Education and Experience** + Minimum 4-7+ years of relevant pharmacovigilance or drug safety experience in the biotechnology or ... Safety Management Team (SMT) meetings to assess drug safety policies, and provide safety...Steering Committee meetings and at partner meetings including Joint Safety Forums (JSFs) and Pharmacovigilance Committee (PVC)… more
- Rhythm Pharmaceuticals (Boston, MA)
- …credentials will be considered if PV experience can be demonstrated. + 1-2 years of Drug Safety and Pharmacovigilance experience. + Knowledge of FDA, ICH, EU ... you will have a critical role in shaping the pharmacovigilance function/department and evaluating the safety of...Regulations and Requirements for Pharmacovigilance required. + Solid understanding of cross-functional … more
- Sumitomo Pharma (Pierre, SD)
- …English. **Education and Experience** + **Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company** + Experience in oncology ... Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters...+ Prepares and presents safety information (ie safety graphs, tables, and reports) to project … more
- Lilly (Indianapolis, IN)
- …fosters inclusion and innovation. + Develop staff who demonstrateexpertise in drug development, therapeutic area science, project management and cross-functional ... This role plays a critical role in ensuring the safety and efficacy of our products while also maximizing...that demonstrates judgment-based decision making and provides leadership in drug development and pharmacovigilance . **6) Understand and… more
- Lilly (Indianapolis, IN)
- …5 years of experience, supporting drug development areas (eg, Safety , Clinical, Project Management, etc.). **Other Information/Additional Preferences:** + ... the world. The purpose of the Sr. Director - Safety Data Scientist role is to provide strategic leadership...elevate the profile of GPS and the science of pharmacovigilance as an essential obligation of the company by… more
- Sanofi Group (Morristown, NJ)
- …BS degree (science, engineering, computer science) or previous experience in Pharmacovigilance Safety Database/validation experience working in a highly ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...the oversight and management of various aspects of the safety database system as well as direct involvement and… more
- BeOne Medicines (San Mateo, CA)
- …Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project /study documents and answer ad-hoc safety queries from ethics committees ... sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report… more
- BeOne Medicines (Emeryville, CA)
- …Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project /study documents and answer ad-hoc safety queries from ethics committees. ... sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug . Experience Report… more
- Boehringer Ingelheim (Ridgefield, CT)
- …antibody-based biotherapeutics, viral, and gene therapies. As the primary interface between global project teams and Nonclinical Drug Safety , the incumbent ... has oversight for the design and execution of nonclinical safety programs to support the development of drug...stages to support asset progression through development; pro-actively manage safety liabilities. + Deliver updates to Project … more
- Taiho Oncology (Princeton, NJ)
- …for responsible compounds, as well as regulatory guidelines as they pertain to drug safety / pharmacovigilance . + Responsible for Individual Case Safety ... and from post-marketing sources, providing medical expertise to assigned project teams, the identification and investigation of safety...+ Minimum of 8 years of experience in a Pharmacovigilance / Drug Safety environment with experiences… more
- Sanofi Group (Waltham, MA)
- …+ Links with other internal stakeholders (such as Regulatory Managers or Product Safety Officers in Pharmacovigilance for DSUR, SMTs) + May represent Sanofi ... **Job Title:** Statistical Project Leader, Deputy Director, Global Biostatistics Sciences **Location**...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
- Sanofi Group (Cambridge, MA)
- …knowledge of product, product environment, and recent literature + Maintain expertise in drug safety and PV, and understanding of international safety ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...pharmacovigilance agreements Impact: + Ongoing assessment of the safety status of the product + Review, preparation, contribution… more
- Takeda Pharmaceuticals (Boston, MA)
- …Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety + ... strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning. + Support… more
- AbbVie (North Chicago, IL)
- …critical role in shaping and driving the strategic priorities of Patient Safety through providing exceptional and strategic project management leadership across ... project management to influence characterization of the compound/product safety & effectiveness profile. This responsibility will be accomplished through… more
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