- 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 ... and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and… 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)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance , regulatory affairs, etc. Qualifications: Successful candidates will be ... able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree an accredited institution in a science or in a technical field preferred - Master's Degree… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 portfolio from the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of ... Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance , CROs and External Vendors for the data services they provide to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance , regulatory affairs, etc. Qualifications: Successful candidates will be ... able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree an accredited institution in a science or in a technical field preferred- Master's Degree… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical direction to MW for the CSR; Working with Clinical Safety Pharmacovigilance (CSPV), defines product level surveillance plan and interpretations, eg language ... for IB; Documents ongoing MM review of data for safety (with CSPV) and quality at project levelStudy Strategy: For Phase 2 and Phase 3 registrational studies: Provides the strategic direction to BDO for EDC, edit checks, data quality listings, SAP, DM plan,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling complies with all… more
- Merck & Co. (Rahway, NJ)
- …Manager, CRM (Clinical Research Manager, TA Head and CRD (Clinical Research Director ) as needed.Works in partnership with GCTO (Global Clinical Trial Operations) ... country operations, finance, regulatory affairs, pharmacovigilance , legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and… more
- Merck & Co. (Rahway, NJ)
- …CRM (Clinical Research Manager), TA Head and CRD (Clinical Research Director ) as needed.-Works in partnership with GCTO (Global Clinical Trial Operations) ... country operations, finance, regulatory affairs,- pharmacovigilance , legal and regional operations, HQ functional areas and externally with-vendors and IRB/IECs and… more
- Amgen (Washington, DC)
- …million patients worldwide. It's time for a career you can be proud of. ** Director , Pharmacovigilance PV Operations, Obesity - US, Remote** **Live** **What you ... will do** Let's do this. Let's change the world. In this vital role you will Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Responsible for overseeing the processing and submission of all individual case safety reports to… more
- AbbVie (North Chicago, IL)
- …detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities: + ... -device combined products + Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory… more
- Ascendis Pharma (Palo Alto, CA)
- …You will be joining the Product Team in Global IT that supports our Pharmacovigilance business function. As IT system manager, you will be supporting Ascendis Pharma ... PV . Deep business process knowledge in either Quality, Regulatory or Pharmacovigilance . . Strong configuration skills . Extensive experience with GxP validation… more
- Amgen (Thousand Oaks, CA)
- …time for a career you can be proud of. **Global Safety Application Development - Director ** **Live** **What you will do** Let's do this. Let's change the world. In ... you will be identifying and providing recommendations to the strategic pharmacovigilance systems roadmap including the global safety database and associated systems,… 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,...support medical surveillance activities and maintain oversight for the Pharmacovigilance Sciences function within the PV department. This includes… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The (Senior Associate) Director will join our motivated and expert team of physicians in the global Cardio-metabolism/Respiratory Therapeutic Area of ... Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of...the opportunity for significant professional development. The (Senior Associate) Director is a key member of global, cross functional… more
- Lundbeck (Deerfield, IL)
- Director Safety Surveillance US - Remote Opportunity Requisition ID: 5214 Location: Deerfield, Illinois, US Do you want to join a team where the mission is ... in the Deerfield, IL office 1-2 times a month.** **SUMMARY:** The Director , Safety Surveillance US will provide strategic leadership to the Safety Scientists… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …teams + Communicates to highest levels of senior management key pharmacovigilance findings + Provides global medical leadership for product-focused safety activities ... + Provides global strategic input to the organization to mitigate pharmacovigilance -related risk + Executes process changes and initiatives based on deep… more
- Ascendis Pharma (Palo Alto, CA)
- The Associate Director Global PV Operations reports directly to the Sr Director , Medical Safety Science-Oncology. Under the direction of the Sr Director , ... PADER, Annual Safety Report, DSUR, IND Annual Report, etc.) + Provides pharmacovigilance expertise to Ascendis or CRO/Vendor staff when needed + Pharmacovigilance… more
- Ascendis Pharma (Palo Alto, CA)
- …at Ascendis Pharma, your role will be to enable our global Medical and Pharmacovigilance (Drug Safety) teams with technology. You will partner with the medical and ... pharmacovigilance teams and lead the product discovery efforts. You...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
