- Tris Pharma (Monmouth Junction, NJ)
- …for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) vendors in all ... opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director ,...periodic benefit risk evaluation reports, etc.) Oversees reconciliation of safety data in pharmacovigilance and clinical trial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …standards for safety and FDA reportability. Serve as the back-up Pharmacovigilance responsible person for NNI. PRODUCT COMPLAINTS: Ensures high quality ... key contact person between NNI Patient Safety , safety vendors and other departments for product ...to case processing activities. Relationships Reports to the Executive Director , NAO Patient Safety with cross-functional working… more
- Insmed Incorporated (Bridgewater, NJ)
- …teams and individuals. Identifies concerns and champions issue resolution.Oversee medical safety and pharmacovigilance activities conducted in partnership with ... or pharmaceutical company, including a minimum of 8 years in a safety -related position.Global Pharmacovigilance experience, including robust knowledge of global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety is diligently considered prior to selecting promising candidates (DP0), allowing product safety leaders (PSLs) and global project teams (GPTs) to enact ... and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded...possible. This led us to create the Translational Patient Safety Senior Director position, which will have… 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: ... harmonization and efficiency which leads to cost savings and accelerated worldwide product submissions and approvals. Authors or initiates writing of global standard… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance , Regulatory/Risk Management, Quality Assurance, ... vendor management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.Work with User Support Leads… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reports to the Director , Case Review & Compliance Reporting within Patient Safety . This position works closely with including, but not limited to the following: ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...of all contract and vendor related activities in Patient Safety including, but not limited to, contract review and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... to unstructured problems with minimal guidance. This position will mainly support New Product Planning and pipeline assets and responsibilities will cover a mix of… more
- Boehringer Ingelheim (Athens, GA)
- **Description** The AD Global PV Data Analysis supports the Global Pharmacovigilance (PV) team to ensure compliance with all regulations and laws worldwide on ... Pharmacovigilance (including but not limited to FDA 21 CFR,...analysis of data sets as on adverse events for safety and efficacy purposes of our veterinary products. +… more
- AbbVie (North Chicago, IL)
- …Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. Leading Product Safety Teams (PST) and supports one or more psychiatry ... or multiple related products for the same indication. Is responsible for assessing product safety strategy across the entire program and for overseeing approval… more
- Boehringer Ingelheim (Ridgefield, CT)
- …assigned drug responsibilities, including: + Continuous monitoring and further development of the product safety profile + Safety issue management + Set-up ... physicians in the global Cardio-metabolism/Respiratory Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority...as required to ensure safe use in patients. The Director may also lead a team of Safety… more
- BeiGene (San Mateo, CA)
- **General Description:** The Senior Medical Director serves as the Product Safety Physician for complex strategically important developmental programs and ... co-ordination, chairs product group meetings across GPS ** Pharmacovigilance ** + Leads and manages safety PV...on the program / portfolio being led. The Medical Director serves as Product Safety … more
- Gilead Sciences, Inc. (Foster City, CA)
- …management key pharmacovigilance findings + Provides global medical leadership for product -focused safety activities + Provides global strategic input to the ... profile of products in therapeutic areas + Defines global product safety strategy and routinely manages and...organization to mitigate pharmacovigilance -related risk + Executes process changes and initiatives based… more
- J&J Family of Companies (Titusville, NJ)
- Director , Safety Surveillance Physician (Hematology &...**Travel** Yes, 10 % of the Time **Job Function** Product Safety Risk Management MD **Req ID:** ... 2406174828W **Description** Johnson & Johnson, is recruiting for a ** Director , Safety Surveillance Physician (Oncology: Hematology &...of adverse event reports within the context of the product 's safety profile as well as other… more
- Taiho Oncology (Princeton, NJ)
- …an Associate Director in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your expertise and ... Associate Director , PV Sciences Pleasanton, CA, USA * Princeton,...have the opportunity to shape the future of drug safety , contribute to groundbreaking research, and advance patient care… more
- AbbVie (North Chicago, IL)
- …LinkedIn. Job Description This position reports into the Office of the Product Safety Team (PST) department within the Pharmacovigilance & Patient Safety ... profile of our drugs to protect patients worldwide. The Director , Product Safety Team Program...strong understanding of the drug development process. Experience within Pharmacovigilance is desirable but not required + 9+ years… more
- AbbVie (South San Francisco, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Product Safety Team (PST) lead for late stage oncology products, under ... responsible to one or more products and will ensuring safety through the product lifecycle (eg surveillance,...PMOS. PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and… more
- BeiGene (San Mateo, CA)
- …(phase II-III) safety science activities. The position has no direct reports. The Director Safety Scientist is part of a team that performs high quality and ... safety expertise for assigned developmental and/or marketed products in conjunction with Product Safety Physician Leads (PSLs) and Safety Physicians.… more
- Bristol Myers Squibb (Princeton, NJ)
- …ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables ... **General Product Support** + Leads signal detection activities for a product 's emerging safety profile. + Provides strong medical writing support for… more
