- Pfizer (New York, NY)
- **ROLE SUMMARY** The Pharmacovigilence AI Quality Oversight Lead is responsible to oversee the strategic development and implementation for the quality ... pharmacovigilance . This involves contributing to and participating in various quality oversight activities/committees established to drive discussion and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , Pharmacovigilance (PV) Operations in Cambridge, MA, where you will ... is processed according to company timelines, performance indicators and quality standards. You will oversee and direct vendor(s) conducting... (PSPV) team you will report to the Executive Director , PV Operations Oversight , and be responsible… more
- Ascendis Pharma (Palo Alto, CA)
- …conduct of MAPs to ensure compliance with PV requirements + Accountable for maintaining oversight over Source data quality check [SDQC] activities and/ or Case ... The Associate Director , Global PV Operations reports directly to the...Safety Report, DSUR, IND Annual Report, etc.) + Provides pharmacovigilance expertise to Ascendis or CRO/Vendor staff when needed… more
- University of Colorado (Aurora, CO)
- …and data quality controls, in close collaboration with the Medical Director and Principal Investigator + Monitors e-mail for safety reports and facilitates a ... and data quality controls, in close collaboration with the Medical Director and Principal Investigator + Monitors e-mail for safety reports and facilitates a… more
- BeiGene (San Mateo, CA)
- **General Description:** The Associate Director R&D Quality Excellence, Analytics, and Innovation is responsible for supporting and maintaining a proactive, ... Technical Solutions + Clinical Operations + Data Management + Risk Based Quality Management + Pharmacovigilance + Clinical Business Operations + Biometrics… more
- Lundbeck (Deerfield, IL)
- Medical Director Global Patient Safety (GPS) US - Remote Opportunity Requisition ID: 5424 Location: Deerfield, Illinois, US Do you want to join a team where the ... of assigned Lundbeck products according to the FDA and global regulatory Pharmacovigilance guidelines. The incumbent will have a strong background and experience… more
- Takeda Pharmaceuticals (Boston, MA)
- …As the Associate Director , Clinical Quality Compliance, you will provide quality oversight to the clinical trial delivery quality systems, promoting ... to the best of my knowledge. **Job Description** **Job Title** : Associate Director , Clinical Quality Compliance **Location** : Cambridge, MA **About the role:**… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Translational Medicine (TM), will be primarily responsible for creating plans for ... in translational studies and with external scientific experts. Reporting into the Senior Director of the Translational Medicine (TM) group, the Director , TM will… more
- Takeda Pharmaceuticals (Boston, MA)
- … Quality (CPMQ) and the CPMQ Leadership Team, driving new opportunities in quality oversight and compliance in clinical trial delivery, providing input into ... R&D Quality 's objectives. + Identifies areas of innovation that impact quality and compliance in clinical trial delivery, pharmacovigilance systems and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …**Job Description** You will act as a primary point-of-contact for R&D Quality inspection management and act as an inspection readiness ambassador, supporting the ... cross-functionally to ensure Gilead's ongoing regulatory compliance and R&D GxP quality operations in accordance with Gilead's Quality Management System… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . ** Director , Medical Safety Assessment Physician (Immunology)** **Functional Area Description** ... is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety… more
- Bristol Myers Squibb (Madison, NJ)
- …presentation, leadership, and strategic skills for their reports. + Provide oversight and ensure quality of disease-specific Lymphoma medical training ... lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Medical Director , US Lymphoma/CLL will report to the Executive Director ,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and ... as well as with business partners to achieve high quality and accurate labeling in support of business objectives....cross-functional labeling review team members. Responsible for the broad oversight of Core Data Sheets and US/EU label changes… more
- AbbVie (Chicago, IL)
- … Director (Epidemiology) is a member of the Global Epidemiology in Pharmacovigilance & Patient Safety, Epidemiology, R&D Quality Assurance (PSEQ). Major ... Director is also responsible (indirectly or through direct oversight ) for developing junior epidemiologists and overseeing data scientists and programmers… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Medical Science MSES, will be primarily responsible for creating plans for ... and in creating and implementing experimental medicine studies. Reporting into the Senior Director of the Medical Science Early-Stage, the Director , MSES will… more
- BeiGene (San Mateo, CA)
- …represent R&D Quality in meetings and discussions, as needed + Act as R&D Quality Delegate for the Executive Director , R&D Quality , as needed + Support ... **General Description:** The Director , GCP Inspection Management, is responsible for: +...+ All R&D Quality Organizations + BGNE Quality Organization + Clinical Operations + Pharmacovigilance … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** Sr. Director Data Management contributes to the vision, direction and strategy for ... members. This position also monitors trends in functional performance via quality , time, and cost indicators, and makes recommendations for improvements.… more
- GE HealthCare (NC)
- **Job Description Summary** As the Associate Director of PV Operations, you will develop/oversee execution of PV processes and deliverables performed internally, ... support of the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of outsourced activities and support departmental budget adherence… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... proper resource allocation for achieving successful project deliverables. Provides oversight of all statistical programming activities performed by contractors in… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …+ Provides regulatory support for MTPA Quality Assurance and Pharmacovigilance inspection ready efforts; and provides regulatory oversight during follow-up ... and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called...teams. + Ensures the overall program execution of high quality , effective IND, CTA, NDA, NDS and MAA and… more