- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early ... as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's global drug … more
- Taiho Oncology (TX)
- …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 MSL 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 scientific expertise and a… more
- Taiho Oncology (New York, NY)
- …as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Uses medical affairs plans to develop and align the ... field tactical plan for MSL geography of responsibility and implement plans to support Medical Affairs strategic direction for assigned territory, eg, medical territory, engagement plans/ SL/HCP Rosters,. Training/Education Resource: Develops, maintains and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …limited to: Global Project Team, Safety Management Team, Clinical Safety and Pharmacovigilance Medical Affairs, Companion Diagnostics/ Device Laboratories ... with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in...agencies required- 10+years of working knowledge of the end-to-end Drug development process in the R&D space required- 10+… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE). - Direct Project Support: ... etc. - Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation of vision and strategy, and identifies technology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE).- Direct Project Support: ... guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation of vision and strategy, and identifies technology… 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 ... As a PV Specialist, you will have a critical role in shaping the pharmacovigilance function/department and evaluating the safety of patients who receive our… more
- ThermoFisher Scientific (Waltham, MA)
- …of experience in the pharmaceutical/biotech industry with at least 5years in pharmacovigilance / drug safety (experience with adverse event monitoring and ... teams within Development. + Progress understanding and education of safety requirements for pharmacovigilance and other relevant...and programs is a plus) + Knowledge of the drug development process, GXP quality and compliance requirements, In… more
- Lilly (San Francisco, CA)
- …a minimum of: 4 years of experience with regulatory requirements and guidelines pertaining to Drug Safety and Pharmacovigilance ; 4 years of experience with ... for people around the world. Eli Lilly and Company seeks an Executive Director, Drug Safety Physician to ensure standard processes and procedures for all aspects… 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 Abilities: + Minimum of 5 years of experience in a Pharmacovigilance / Drug Safety environment with substantial experience in managing adverse event… more
- Amgen (Thousand Oaks, CA)
- …interdepartmental & international programs and projects + Understanding of international drug safety regulations, global pharmacovigilance , and product ... Previous product safety experience and knowledge of clinical trials and drug development + Knowledge of Cardiovascular, Nephrology & Bone patient populations and… more
- J&J Family of Companies (Horsham, PA)
- …(J&J IM) US Commercial Operating Companies (OpCo) in support of the US Local Safety Officer (LSO) / US Pharmacovigilance Officer (PVO). Under the direction of ... Associate Director, US Pharmacovigilance - 2406194496W **Description** At Johnson & Johnson...* Conducts ongoing assessment of IM OCMO and other safety -related controlled documents for applicability of content/subject matter by… more
- Sanofi Group (Morristown, NJ)
- …for pharmacovigilance regulations, and a commitment to maintaining the highest standards of drug safety , we invite you to apply. Be part of our mission to ... to safety management activities in cooperation with CHC Global Pharmacovigilance (GPV), Country PV teams, HA (Health Authorities), partner companies and other… more
- Amgen (Washington, DC)
- …with these qualifications. **Basic Qualifications:** Doctorate degree and 2 years of safety / pharmacovigilance experience OR Master's degree and 4 years of ... guidance of GSO + Support activities related to new drug applications and other regulatory filings + Assist GSO... safety / pharmacovigilance experience OR Bachelor's degree and... safety / pharmacovigilance experience OR Bachelor's… more
- AbbVie (North Chicago, IL)
- …clinical development or PV experience in Psychiatry + Minimum 5-7 years experience in drug safety and/or a related discipline in the pharmaceutical industry + ... signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities: +… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and post-market support + Strong knowledge of global regulatory requirements related to pharmacovigilance and drug safety . + Strong knowledge in signal ... safety topics for products working closely with Drug Safety Global Safety Team... safety conclusions, and their impact for product safety profile. + Mentor junior pharmacovigilance (PV)… more
- AbbVie (North Chicago, IL)
- …to launch to market. + 5 years should be in Drug Safety /Surveillance. + 5 years management experience in Pharmacovigilance ; demonstrated ability to manage ... safety database and search strategy, construction/maintenance) and Global Pharmacovigilance Medical Device functionality (coordination of processing and US… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …with significant knowledge of relevant regulatory requirements and substantial knowledge of drug safety including previous experience in a leadership role in ... Serves as a senior scientific and clinical expert for safety profile of products in therapeutic areas + Defines...preferred. + 6+ years (with MD or PharmD) in pharmacovigilance , drug development or applicable role in… more
- Boehringer Ingelheim (Ridgefield, CT)
- …disciplines as appropriate + Provide updates of the assigned drug 's safety profile to senior management and recommend pharmacovigilance / risk management ... team of physicians in the global Cardio-metabolism/Respiratory Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing… more
- Taiho Oncology (Princeton, NJ)
- …part of our team, you'll have the opportunity to shape the future of drug safety , contribute to groundbreaking research, and advance patient care worldwide. With ... as an Associate Director in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your expertise… more
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