- Nuvalent, Inc. (Cambridge, MA)
- …development, and company building. The Role: Reporting to the Senior Medical Director, Pharmacovigilance , the Associate Director, Drug Safety and ... knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …3 years of management experience in PV preferredMinimum of 5 years of Drug Safety / Pharmacovigilance experience, including both investigational and marketed ... around rare diseases and immune disorders. Job Summary: Manage Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual … 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 ... marketed products; preferredExtensive knowledge of AE and drug coding conventions (MedDRA, WHO-DD). preferredExtensive knowledge of FDA regulations, clinical and … more
- Deciphera Pharmaceuticals (Waltham, MA)
- …preferred; board eligible or OUS equivalent) Minimum of 5 years of experience in Pharmacovigilance / Drug Safety with development and marketed products in a ... informed of safety issues. May represent Deciphera, Drug Safety and Risk Management at internal...systems as they are implemented Working knowledge of global drug development and pharmacovigilance guidelines and regulations… more
- Taiho Oncology (FL)
- …as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Use medical affairs plans to develop and align the ... tactical plan for Sr. Manager, Medical Field geography of responsibility and implement plans to support Medical Affairs strategic direction for assigned territory, eg medical territory plan Training/Education Resource: Develop, maintain and demonstrate… more
- Pharmacy Careers (Huntington Beach, CA)
- Pharmacovigilance Pharmacist Bring your clinical lens to the world of drug safety and reporting. Key Responsibilities: Analyze adverse event reports and ... Qualifications: PharmD with strong understanding of pharmacology. Prior experience in drug safety or clinical data review is a plus. Detail-oriented with… more
- BioSpace (Bridgewater, NJ)
- …identifying trends and implementing corrective and preventative actions. Oversee medical safety and pharmacovigilance activities conducted with external partners ... (TM) lists. Overview The Executive Director (ED) will lead Global Medical Safety Strategy for all Insmed's investigational and marketed products while spearheading… more
- Formation Bio (New York, NY)
- …regulatory documents (meeting and briefing packages, regulatory filings); and pharmacovigilance documents (eg, annual reports/developmental safety update ... is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more… 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
- 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 (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
- Taiho Oncology (Princeton, NJ)
- …for responsible compounds, as well as regulatory guidelines as they pertain to drug safety / pharmacovigilance . + Responsible for Individual Case Safety ... Skills, and Abilities: + Minimum of 8 years of experience in a Pharmacovigilance / Drug Safety environment with experiences in managing adverse event and SAE… more
- Takeda Pharmaceuticals (Boston, MA)
- …preferred. + At least 5 years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance , with both investigational and marketed products. ... Company-wide patient safety expert for assigned pharmaceutical / biological / drug -device combined products, accountable for the safety strategy and major … more
- Astrix Technology (Chicago, IL)
- …a relevant specialty is preferred. + Minimum of 3 years of experience in pharmacovigilance or drug safety within the pharmaceutical or biotechnology ... ** Drug Safety Physician** Clinical Chicago, IL,...to health authority inquiries. + Stay current with global pharmacovigilance regulations and guidelines to ensure compliance and best… more
- Astrix Technology (Monmouth County, NJ)
- …with a focus on pharmacovigilance or regulatory affairs. + Strong knowledge of drug safety regulations and pharmacovigilance systems. + Proficiency with ... SOPs, and quality standards. + Collaborate with cross-functional teams including drug safety , regulatory affairs, clinical development, and biostatistics. +… 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 ... **Job Title:** PSPV Global Translational Safety Lead **Location** : Cambridge, MA or Morristown,...healthcare, human biology, data management and systems, epidemiology, pharmacology, pharmacovigilance , drug development and statistics + … 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
- Sanofi Group (Morristown, NJ)
- …Participation in the ongoing permanent inspection preparedness and readiness of Patient Safety and Pharmacovigilance (PSPV) and country PV offices in ... **Job Title:** Pharmacovigilance Audit and Inspection Readiness Expert **Location:** Morristown,...of medicine? The race is on to speed up drug discovery and development to find answers for patients… 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 ... Evaluation and Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters + Handles Health… more
- Amgen (Washington, DC)
- …experience **Preferred Qualifications:** + Healthcare professional background + 1 year of drug safety /PV experience + Experience in signal detection, evaluation ... the lives of patients while transforming your career. Global Pharmacovigilance (PV) Scientist **What you will do** Let's do...team of PV Scientists working in collaboration with Global Safety Officers (GSO) to provide the safety … more
