- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to execute audits effectively.Support inspection readiness by preparing clinical teams, Clinical Safety and Pharmacovigilance (CSPV) and post marketing ... industry, with involvement in regulated clinical trials, clinical safety , pharmacovigilance included regulatory document reviewMust have at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management experience in PV preferredMinimum of 5 years of Drug Safety / Pharmacovigilance experience, including both investigational and marketed products; ... required4 or More Years Knowledge of Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures...(GVP) required4 or More Years Knowledge of FDA regulations, clinical and safety databases; preferred4 or More… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical and safety databases, preferredFamiliarity with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP) preferred Daiichi ... in PV; required10 or more years of experience within Drug Safety / Pharmacovigilance experience, including both investigational and marketed products;… more
- Taiho Oncology (FL)
- …defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Use medical affairs plans to develop and align the tactical plan ... practitioners on Taiho products and relevant disease states, and facilitation of clinical research. The Sr. Manager, Medical Field integrates clinical /scientific… more
- Deciphera Pharmaceuticals (Waltham, MA)
- … (PV) for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the ... board eligible or OUS equivalent) Minimum of 5 years of experience in Pharmacovigilance /Drug Safety with development and marketed products in a biopharmaceutical… more
- Hays Recruitment (Philadelphia, PA)
- …to assess product safety and support decision-making. *Provide safety -related input into clinical trials, marketing authorization applications (MAAs), ... field, or equivalent experience. *Minimum of 8-10 years of experience in pharmacovigilance or drug safety . *In-depth knowledge of regulatory requirements and… more
- Pharmacy Careers (Corona, CA)
- Pharmacovigilance Pharmacist Bring your clinical lens to the world of drug safety and reporting. Key Responsibilities: Analyze adverse event reports and ... clinical trial safety data. Prepare regulatory submissions (eg, MedWatch, PSURs). Collaborate with medical affairs and clinical teams to address safety … more
- Anavex Life Sciences Corp. (New York, NY)
- …related to company sponsored clinical trials to provide required pharmacovigilance contributions such the drafting of Safety Management Plan (SMP), ... clinical trials subjects Work in collaboration Global Clinical Operations to maintain the pharmacovigilance section...Master File/Sponsor Oversight Files to ensure sections related to clinical safety are accurate and up to… more
- Miltenyi Biotec (Waltham, MA)
- …requirements for expedited reporting. Contribute to development of protocol specific safety definitions, in collaboration with multi-departmental clinical trial ... approach for safety evaluations. Serve as drug safety representative on clinical trials with CRO...specialty is a plus; Minimum 3 years of Drug Safety / Pharmacovigilance Development (Early and/or Late Phase: develop… more
- Takeda Pharmaceutical Company Limited (Cambridge, MA)
- … safety information for studies and compound in conjunction with Pharmacovigilance . Oversees non-medical clinical scientists with respect to assessment of ... charge of your future at Takeda. Join us as a Senior Medical Director, Clinical Science Neuroscience, Sleep Disorder, in our Cambridge, MA office. At Takeda, we are… more
- AbbVie (North Chicago, IL)
- …pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for ... representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to… more
- Takeda Pharmaceuticals (Boston, MA)
- … safety -elated regulatory authority requests (2 years); apply clinical trial methodology, various regulatory submissions, pharmacovigilance regulations, and ... including the ability to perform advanced searches. + In-depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety profile, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …partnership with functional compliance teams for regulations impacting Clinical , Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes ... best of my knowledge. **Job Description** **About the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the… more
- BeOne Medicines (San Mateo, CA)
- …colleagues in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, ... equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports; + Clinical sections of Health Authority… more
- BeOne Medicines (San Mateo, CA)
- …colleagues in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, ... equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority… more
- BeOne Medicines (Emeryville, CA)
- …colleagues in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, ... equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority… more
- Bristol Myers Squibb (San Diego, CA)
- …be the global leader in radiopharmaceuticals . The Executive Director, Head of Pharmacovigilance - Safety Science, is responsible for overseeing all aspects of ... product safety across clinical development and post-marketing surveillance....equivalent (MBBS etc) + 10+ years of experience in pharmacovigilance , safety science, or related area within… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …is preferred (MS, Pharm.D.) + At least one year of relevant experience in pharmacovigilance , clinical research, or regulatory affairs in a CRO or a ... guidelines + Expertise in therapeutic products and areas; medical coding; safety -data administration + Pharmacovigilance Specialist should possess autonomy and… more
- Sanofi Group (Morristown, NJ)
- …and evaluation to patient risk profiling, patient safety experience and clinical data. + Collaborate within Global Pharmacovigilance for optimizing signal ... non- clinical and emerging preclinical data into potential clinical risk + Support Pharmacovigilance teams including...of pipeline programs + Contribute to the interpretation of pre- clinical and existing clinical safety … more
- Amgen (Washington, DC)
- …Amgen partner regarding products + Support and provide oversight to staff with regards to safety in clinical trials to review and provide input and support on ... the lives of patients while transforming your career. **Global Pharmacovigilance (PV) Senior Scientist** **What you will do** Let's...Review standard design of tables, figures, and listings for safety data from clinical studies + Participate… more
