- Unknown (Bothell, WA)
- Vice President, Pharmacovigilance & Drug Safety About the Company Innovative biotechnology (BioTech) company specializing in antibody-based therapeutics ... the Role The Company is seeking a Vice President, Pharmacovigilance & Drug Safety to...to work collaboratively in a fast-paced, dynamic environment. Hiring Manager Title Chief Medical Officer Travel Percent Less than… more
- Unknown (San Diego, CA)
- Executive Director, Drug Safety & Pharmacovigilance ...the ability to lead and train a team. Hiring Manager Title Head of Safety Travel Percent ... B2B B2C About the Role The Company is seeking an Executive Director for Drug Safety and Pharmacovigilance . The successful candidate will be at the forefront… more
- Unknown (Portland, OR)
- …medical safety professionals and PV scientists, and ensuring compliance with drug safety and pharmacovigilance regulations. The Executive Medical ... (MD) and a minimum of 8 years' experience in drug safety or pharmacovigilance within...ability to work in a fast-paced, dynamic environment. Hiring Manager Title SVP, Global PV & Risk Management Travel… more
- Unknown (Tarrytown, NY)
- …clear direction on medical affairs activities, including clinical studies and pharmacovigilance . Hiring Manager Title Chief Executive Officer Travel Percent ... for Quality Assurance and Regulatory Affairs to ensure the compliance and safety of its diverse product portfolio. The successful candidate will be responsible… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Manager , Pharmacovigilance Department: Pharmacovigilance Location: Elmwood Park, NJ START YOUR APPLICATION ... in North America: USA & Canada. This person will assist with managing the safety tasks performed by a Pharmacovigilance provider with focus on efficient,… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …aggregate reports preparation, signal management and ad hoc requests. + Support drug safety systems through business administration tasks, including database ... like you. Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure… more
- PSKW LLC dba ConnectiveRx LLC (Whippany, NJ)
- …the Specialist, Pharmacovigilance is focused on meeting ConnectiveRx's obligations for Drug Safety Monitoring and Reporting as required by the pharmaceutical ... potential sources of safety information under the guidance of the Manager , Pharmacovigilance . Sources may include recorded calls, claims, faxes, text… more
- Lilly (Indianapolis, IN)
- …system change management process for PV systems. + Perform configuration of PV safety systems such as global reporting rules and conducting Product License Study ... activities. PV Data Reporting & Compliance + Provide PV and Lilly safety reports through existing/adhoc queries with high quality and accuracy through appropriate… more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. Global Safety Senior Manager , Rare Disease **What you will do** Let's do this. ... 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 in… more
- Takeda Pharmaceuticals (Boston, MA)
- …of data visualization tools such as Tableau/Spotfire is preferred + Knowledge of drug safety regulations (eg, ICH, FDA, EMA guidelines) and pharmacovigilance ... that will inspire you and empower you to shine? Join us as a Senior Manager , Global Safety Database Configuration in our Cambridge, MA office. At Takeda, we… more
- BeOne Medicines (Emeryville, CA)
- … sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug . Experience Report ... medical field or biological science and 8+ years of experience as a Safety ( Pharmacovigilance ) Scientist. + MD (or internationally recognized equivalent) plus… more
- CSL Behring (King Of Prussia, PA)
- …roles and regulations, locally as well as globally. + Expert knowledge of drug safety processes, pronounced expertise in Single Case Management, in terms ... to the Head of Risk Management, Aggregate Reports & Pharmacovigilance , as the **Senior Manager , ICSR Quality**...be responsible for ensuring optimal quality of Individual Case Safety Reports (ICSRs) in the Global Safety … more
- Sumitomo Pharma (Providence, RI)
- …collaboration with external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements ... a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to… more
- IQVIA (New York, NY)
- ** Manager , Medical Affairs Strategy** **Overview** IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to ... clients are looking for insight and evidence on the safety , efficacy, and cost-effectiveness of their products across a...solutions as well as exceptional professional development. As a Manager , you will have the opportunity to directly address… more
- Bristol Myers Squibb (San Diego, CA)
- …(eg, INDs, CTAs, NDAs, MAAs, briefing documents) + Patient narratives and safety summaries + Ensure all documents comply with regulatory guidelines (ICH, FDA, ... Coordinate with cross-functional teams (clinical, regulatory, biostatistics, data management, pharmacovigilance , clinical operations and other departments) for source data,… more
- System One (East Windsor, NJ)
- …Sterile Injectable Products Responsibilities: + Under the oversight of the Associate Manager of Quality Assurance (QA) Compliance, this position will be responsible ... establishing the internal QA review system to supervise the Pharmacovigilance Group (PVG) function, which is handled by a...a QA system to notify the US Food and Drug Administration (FDA) of illegitimate products, as and when… more
- Sanofi Group (Morristown, NJ)
- …including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research &… more
- Sanofi Group (Morristown, NJ)
- …for the clinical studies on activities pertaining to the Study Medical Manager (SMM) responsibilities eg: leading or contributing to key study documents and ... opportunities in the therapeutic area. + Under the guidance of his/her manager in the Therapeutic Area department, he/she collaborates with the Coding specialist,… more
- Parexel (Columbia, SC)
- …of Medical Monitoring and study design/execution, preferred * Good knowledge of the drug development process including drug safety , preferred * Excellent ... clients in the journey of getting new and innovative drug treatments into the hands of those who need.../ Medical Director are to: * Provide medical and safety monitoring for assigned projects * Provide medical expertise… more
- Sanofi Group (Morristown, NJ)
- …all function stakeholders (eg clinical operations, project management, Patient Safety and Pharmacovigilance , regulatory, Finance, Scientific External Engagement, ... under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver… more
