- Insmed Incorporated (Bridgewater, NJ)
- …to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner managing quality ... Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical /Clinical Departments. The incumbent will provide support… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) vendors in all aspects of PV activities for products both… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early...led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance , CROs and External Vendors ... opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and ... innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director , is a subject matter expert in CDISC Controlled Terminology… more
- AbbVie (North Chicago, IL)
- …strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans + ... medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Chair the Asset Benefit Risk Team consisting of experts in Pharmacovigilance , Medical Affairs, Epidemiology and Biostatistics and other disciplines as ... assigned drug's safety profile to senior management and recommend pharmacovigilance / risk management activities to BI...compound, may be required to strategically lead, manage and medical -scientifically direct a team of risk management… more
- Taiho Oncology (Princeton, NJ)
- …collaboration with the Medical Surveillance team. + Lead development/maintenance of Risk Management Plans (RMP) and associated pharmacovigilance and risk ... an Associate Director in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your expertise and… more
- Lundbeck (Deerfield, IL)
- …+ Excellent working knowledge of local and global regulations/guidelines in pharmacovigilance and risk management, REMS programs. + Detailed understanding ... Director Safety Surveillance US - Remote Opportunity Requisition...will maintain oversight of safety related post approval commitments, risk minimization activities and any mandated REMS programs throughout… more
- BeiGene (San Mateo, CA)
- …signal evaluation/safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/ risk and regulatory activities and ... risks that could result in changes to labels and/or benefit- risk profile + Propose and lead data acquisition strategy,...expertise for development of Protocols, IBs, ICFs, SAPs/ TFLs, Medical Monitoring Plans, CSRs (incl. China ADR Summary) and… more
- J&J Family of Companies (Titusville, NJ)
- Director , Medical Safety Officer, Oncology - 2406185159W **Description** Johnson & Johnson, is recruiting for a Director , Medical Safety Officer, ... cross-functional matrix teams responsible for product safety and benefit risk oversight and represents Global Medical Safety...will communicate potential and known risks and changes to benefit/ risk , when appropriate, to the Sr. Director … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …teams + Communicates to highest levels of senior management key pharmacovigilance findings + Provides global medical leadership for product-focused ... activities + Provides global strategic input to the organization to mitigate pharmacovigilance -related risk + Executes process changes and initiatives based on… more
- BeiGene (San Mateo, CA)
- …signal evaluation/safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/ risk and regulatory activities and ... science activities. The position has no direct reports. The Director Safety Scientist is part of a team that...a matrix team to conduct safety assessment and safety risk management activities, based on ICH standards. The person… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Medical Safety Physician will join our motivated and expert team of physicians in the global Oncology Therapeutic Area of Patient Safety and ... Pharmacovigilance at BI, whose priority is the wellbeing of...highly visible role for an individual with a strong medical /scientific background who is inspired by prioritizing patient safety… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Medical Safety Physician will join our motivated and expert team of physicians in the global CREA Therapeutic Area of Patient Safety and ... Pharmacovigilance at BI, whose priority is the wellbeing of...highly visible role for an individual with a strong medical /scientific background who is inspired by prioritizing patient safety… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and maintaining valuation models and transactional, diligence and integration processes. The Medical Director , Medical Safety Officer (Clinical) plays a ... Clinical Safety Forums with the BU CSS + Providing medical support for Risk Strategy, Risk...to the Severity of Harm determinations used throughout the risk management process + Knowledge of pharmacovigilance … more
- AbbVie (South San Francisco, CA)
- …for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...PMOS. PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Our dedicated TA CRM Team is looking for an experienced Executive Director of Patient Safety Physician with expertise in cardiovascular, renal, metabolic, and/or ... & Responsibilities** + Lead a team responsible for the development of proactive risk management strategies for a portfolio of core strategic (high profile and/ or… more
- AbbVie (North Chicago, IL)
- …products + Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, ... medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's… more
- AbbVie (North Chicago, IL)
- …products + Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, ... medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's… more
