- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Business Partners as required to assure compliance with PV agreements. Participate in audit and inspection readiness activities. Provide input for ... around rare diseases and immune disorders. Summary: Oversees Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …local/affiliate SDEA templates meet both Global and local regulatory requirements Supports audit and inspection readiness Develops and maintains company ... Essential Functions Administration: Exercises considerable latitude and applies extensive pharmacovigilance knowledge and technical expertise in determining and implementing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …performance metrics to ensure departmental KPIs and regulatory compliance are consistently met Audit & Inspection Readiness Support the preparation and ... external audits and regulatory inspections Ensure documentation and processes are audit -ready and aligned with global pharmacovigilance standards Physical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Medical Review Prospective & Retrospective Quality Review of cases Regulatory Intel & Inspection Readiness Maintains up to date knowledge of the regulations and ... external audits and regulatory inspections Ensure documentation and processes are audit -ready and aligned with global pharmacovigilance standards Physical… more
- Aequor (Thousand Oaks, CA)
- …to the Digital QMS platform for health and control processes. Leads Digital QMS audit & inspection readiness , deviations and change control activities Manage ... Experience with risk-based Supplier Quality Management process. Management of Global Inspection and Audit programs Proficient working on multiple projects… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or committees and external environments at a global and regional level as required.Support audit and inspection readiness activities as a subject matter ... of continuous improvement in benefit-risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual will be the main… more
- Parexel (Des Moines, IA)
- …approach. The CQOM will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up ... NGO, government or academic institutions). + Facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, the CQOM will… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Pharmacovigilance Audit and Inspection Readiness Expert **Location:** Morristown, NJ **About the Job** Are you ready to shape the future ... critical in helping our teams accelerate progress. Join our Pharmacovigilance Audit and Inspection Readiness team as an Expert. We are an innovative… more
- Gilead Sciences, Inc. (Foster City, CA)
- …assessment activities, in partnership with risk program and SMEs. + Support the overall inspection readiness of the GVP Audit program, including preparation ... changing legislation, and relevant Gilead policies and procedures supporting audits and pharmacovigilance activities. + Execute on the strategic audit plan.… more
- Boehringer Ingelheim (Duluth, GA)
- …SOPs and related documents in a culture of continuous improvement. + Ensures audit / inspection readiness and represents Boehringer Ingelheim in audits and ... Product Surveillance & Risk Management (PSRM) program within Global Pharmacovigilance (GPV). The incumbent translates evolving and complex regulatory authority… more
- Lilly (Indianapolis, IN)
- …, coordination, back room, front room, responses). + Communicate and ensure inspection readiness (for example, organization and availability of documents such ... to ensure compliance, quality oversight of business areas to integrate requirements, audit / inspection support and collaboration within quality and other areas.… more
- System One (Plainsboro, NJ)
- …, and cross-functional collaboration across our global safety network. Key Responsibilities Inspection & Audit Readiness - Actively participate in ... control and documentation tracking, oversight of agenda and deliverables. - Maintain inspection readiness at all times by routinely overseeing critical… more
- Pfizer (Collegeville, PA)
- …Research & Communications activities, including methodological improvements + Engages in inspection readiness support including provision of data to project ... functions engaged in benefit-risk management (Regulatory, Quality, Clinical, Medical, Corporate Audit , etc) to enable one medical voice + Articulates clear and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …activities are carried out with high quality and compliance. + Promotes inspection readiness for clinical trials and strategic supplier activities, ensuring ... roles involving quality systems and clinical portfolio oversight, large-scale audit programs, regulatory inspection management, investigation and remediation… more
- System One (Armonk, NY)
- …clinical trials, inclusive of issue management and providing continuous support of inspection readiness . In this role, a typical day might include ... compliance support to cross-functional stakeholders, including issue management (triage/investigation/actions), audit responses, proactive quality management, Corrective Action/Preventive Action (CAPA)… more
