- 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
- 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
- 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
- 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. (Parsippany, NJ)
- …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
- 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
- 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 (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
- BeiGene (San Mateo, CA)
- …in this position provides safety expertise for assigned compounds with Product Safety Physician Leads (PSLs). Represents GPS department internally and ... safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/risk and regulatory activities and interactions._… more
- J&J Family of Companies (Raritan, NJ)
- … product spokesperson regarding overall benefit/risk. The MSO will report to the GMS Sr. Director Product Safety Head, Oncology and oversee the safety ... potential and known risks and changes to benefit/risk, when appropriate, to the Sr. Director Product Safety Head, the VP Therapeutic Area Safety… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Plans + Clinical Overview Statements + Continuous monitoring and further development of the product safety profile + Safety issue management + Set-up of ... physicians in the global Oncology Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority...hired_** **_at level commensurate with experience and education._** **Associate Director Requirements:** + US MD or DO degree or… 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
- Lilly (Indianapolis, IN)
- …through philanthropy and volunteerism. **Purpose:** The purpose of the Medical Device Safety Scientist Associate Director role is to leverage clinical and ... scientific expertise working across Lilly's device product portfolio to lead the completion of ...+ Consult and coordinate with the Device Surveillance Senior/Executive Director and Device Safety Physician to facilitate… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Product Safety Team (PST) lead for early oncology products, under the ... clinical safety , and will be interpreting regulations related to pharmacovigilance to support all patient safety activities. Responsibilities: +… more
