- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program level and along the GvP modules in support of a proactive quality risk management process.Interact with the audit and compliance function for the ... PV risks identified through audits, inspections, internal meetings, remediations and risk management in close collaboration with the organization's quality … more
- Merck & Co. (North Wales, PA)
- …area accountabilities for the scoping & implementation and maintenance of each PV system release, in support of PV OperationsCollaborate with cross-functional ... business casesTrack the projects from ideation till completionEnsures project management tools are availableEducation RequirementsBS degree required, master's preferredNOTICE… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the GMP road map to meet changing regulatory and business needs.Lead remediation and risk management to assure the organization's Quality Management System ... enhancing globalization at DS QA-GMP affiliates. Proactively supports Global QA CMO Management and Global QA Audit Program teams.Responsible to ensure that quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current clinical practice ... reviews and provides written assessments of relevant medical topics, and supports PV Operations' medical review function. This position supports a senior physician… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Director , PV Risk Management in Cambridge, MA with the ... experience must include: Strategize, author, and review Global and European Risk Management Plans (RMP) Core-RMP, EU-RMP other RMP including those for first… more
- Ascendis Pharma (Palo Alto, CA)
- …for assigned activities + Is responsible for any assigned US applicable Risk Management Plan + Implementation Coordination activities and associated tracking ... The Associate Director Global PV Operations reports directly...Management Teams (SMTs) as an active member representing PV Operations team. + Participate in the conduct of… more
- Taiho Oncology (Princeton, NJ)
- …in collaboration with the Medical Surveillance team. + Lead development/maintenance of Risk Management Plans (RMP) and associated pharmacovigilance and risk ... Associate Director , PV Sciences Pleasanton, CA, USA...and escalate as needed, to enhance medical surveillance and risk management process towards continuous improvement and… more
- Taiho Oncology (Princeton, NJ)
- …of a more complex nature and/or global products that are marketed with risk management programs. Performance Objectives: + Maintains expert knowledge of safety, ... Sr. Director , PV Medical Surveillance Princeton, NJ,...managing adverse event and SAE processing, medical surveillance and risk management , signal detection, on a global… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The Director , Quality Management System (QMS) Governance, Quality Planning, and Risk Management is accountable to ... inform Departmental, Functional Area strategy. + Expert - Demonstrated success driving Risk Management and Quality Objective implementation. + Advanced -… more
- J&J Family of Companies (Horsham, PA)
- Associate Director , US Pharmacovigilance - 2406194496W **Description** At Johnson & Johnson Innovative Medicine we believe health is everything. Our strength in ... environment where all employees can achieve their potential. The Associate Director , US Pharmacovigilance is responsible for overseeing the Pharmacovigilance ( PV… more
- BeiGene (San Mateo, CA)
- …maintenance of product safety profile + Develop content for epidemiologic sections of risk management plans, benefit risk assessments and regulatory ... and implement a Global PE strategy **Develop and Implement PV -Epi Research Program for Safety Issues** + Develop product...(for relevant areas) and review data and draft response ** Risk Management Plan development** + Contribute to… more
- Lundbeck (Deerfield, IL)
- …and clinical trials, the detection and evaluation of safety signals and risk management activities. Additional responsibilities include contribution to the ... Medical Director GPS US - Remote Opportunity Requisition ID:...Safety Team members, as well as safety governance bodies ** Risk Management ** + Maintains oversight of … more
- AbbVie (North Chicago, IL)
- …with other GPV and AbbVie functions conducting periodic reporting, product surveillance, risk management , and legal efforts to provide adverse event data ... and to develop/implement successful solutions by leading the Global Case Management (GCM) function, translating the business vision into broad and actionable… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …levels, effectively communicating safety viewpoints and findings as required, and recommended risk management and minimization activities. + Ability to utilize ... Therapeutic Area (TA) Head of General Medicines, the Senior Director is a key role that contributes to the...product safety governance teams as Chair of the Safety Management Team (SMT) and a member of the cross-functional… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …levels, effectively communicating safety viewpoints and findings as required, and recommended risk management and minimization activities. + Ability to utilize ... in a matrix environment within and external to GPS including senior management . The GPS Director joins Regeneron's industry leading scientific organization,… more
- Merck (North Wales, PA)
- **Job Description** Primary responsibilities include: **Safety platform release management ** + Manage the business area accountabilities for the scoping & ... implementation and maintenance of each PV system release, in support of PV ...the projects from ideation till completion + Ensures project management tools are available **Education Requirements** + BS degree… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …levels, effectively communicating safety viewpoints and findings as required, and recommended risk management and minimization activities. + Ability to utilize ... Patient Safety (GPS) Therapeutic Area (TA) Head, the Senior Director , serves as the first point of contact (POC)...Program Team (SPT) and the Chair of the Safety Management Team (SMT) for the compound. The GPS Lead… more
- J&J Family of Companies (Raritan, NJ)
- …globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans + Able to plan ... Director , Medical Safety Officer, Solid Tumor Oncology -...Head (TASH), the Head of Global Safety Strategy & Risk Management (GSSRM), the Chief Safety Officer… more
- J&J Family of Companies (Horsham, PA)
- …globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans + Able to plan ... Director , Medical Safety Officer, Neuroscience and Ophthalmology -...SMT responsibilities include safety surveillance (including signal detection) and risk management activities (including Risk … more
- ThermoFisher Scientific (Wilmington, NC)
- …reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities. + Medically reviews adverse event and ... pharmaceutical product life-cycle. **General Support:** + Ensures tasks delegated to PV are properly executed. Adheres to applicable regulations and ICH guidelines… more
