- Grifols Shared Services North America, Inc (Clayton, NC)
- …like you. Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure ... high-quality pharmacovigilance deliverables that comply with global regulatory reporting timelines....IT-related PV projects. + Drive Innovation through AI in Pharmacovigilance : Stay at the forefront of artificial intelligence advancements… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create more tomorrows. **Job Description** The **Head of Safety and Pharmacovigilance - Cell Therapy** leads a specialized and expanding global team of ... strategic direction, governance, and operational execution of safety and pharmacovigilance activities for both investigational and marketed products. Reporting to… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …**Job Description** We are seeking an exceptional leader to Head Pharmacovigilance and Medical Affairs including medical information function for Dr. Reddy's ... agency (FDA/Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US… 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 of medicine? ... skills could be critical in helping our teams accelerate progress. Join our Pharmacovigilance Audit and Inspection Readiness team as an Expert. We are an innovative… more
- Rhythm Pharmaceuticals (Boston, MA)
- …PV Specialist, you will have a critical role in shaping the pharmacovigilance function/department and evaluating the safety of patients who receive our medications. ... Rhythm's safety vendor. This position will report to the Director of Pharmacovigilance . Responsibilities and Duties + Reviews adverse event information received for… more
- Merck (Rahway, NJ)
- **Job Description** **The Senior Specialist, Global Pharmacovigilance will be responsible for some or all of the following core activities:** + Case review/approval ... procedure management + Support training + Provide business support for pharmacovigilance database systems (eg, review validation documents and execute User… more
- Colgate-Palmolive (Piscataway, NJ)
- …Summary** Serve as the Lead point of contact for all Global Pharmacovigilance functions and processes for internal & external customers and stakeholders. Contribute ... functions in delivering vision, training and awareness of Global Pharmacovigilance to PV and all Colgate-Palmolive employees + Lead...Qualifications** : + 5 years or more working within Pharmacovigilance + MD, DM or PharmD degree **Skills:** +… more
- United Therapeutics (Concord, NH)
- …compliance with respect to ISCR processing and reporting. The Lead Pharmacovigilance QC Specialist provides strategic oversight of end-to-end case safety quality, ... biology, or BSN, and 8+ years of experience in pharmacovigilance in either case processing or quality assurance of...chemistry or biology, and 6+ years of experience in pharmacovigilance in either case processing or quality assurance of… more
- Sumitomo Pharma (Augusta, ME)
- …+ Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance . + Excellent interpersonal skills, with demonstrated ability to work in a ... Experience in oncology is highly desired + **Advanced understanding of pharmacovigilance and risk management regulations and guidelines, including pre- and… more
- US Tech Solutions (CA)
- …* Perform **quality review** of **external providers'** reconciliation tasks for clinical and post-marketing ( **medical information, product complaints, and ... This role will be 100 % remote. Candidates must posses **3 to 5 years of experience** or application/environment specific knowledge to perform tasks where large quantities of information, data or documents need to be maintained or manipulated in a **structured… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …President (VP) of GPS Operations is responsible for overseeing the global pharmacovigilance areas of Case Evaluation and Reporting (CER), Quality and Compliance ... proven abilities with team development, in depth understanding of pharmacovigilance operations, quality and compliance, planning, and assessing and implementing… more
- Lilly (Indianapolis, IN)
- …and in support of the European Union Qualified Person for Pharmacovigilance (EU QPPV). **Benefit-Risk Management** **Leadership** **1) End-to-End Business Process ... internal expert to provide specialized knowledge within the area of Pharmacovigilance risk management and risk minimization activities. + Collaborate with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** The Associate Director, Good Pharmacovigilance Practice (GVP) Audits, serves as a key role within Gilead's ... lead complex audits across the broader R&D, vendor, and pharmacovigilance workstreams. This position requires close collaboration with cross-functional stakeholders,… more
- Takeda Pharmaceuticals (Boston, MA)
- …**OBJECTIVES:** + Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business ... affiliate and enables them to deliver their clinical research and pharmacovigilance -related regulated activities with high compliance and agility. + Establish and… more
- United Therapeutics (Columbus, OH)
- …You have a background in nursing or pharmacy and you're passionate about pharmacovigilance ! You are a team player who loves quality, compliance, finding solutions ... practices. They will serve as a Subject Matter Expert for pharmacovigilance (PV), quality practices, education/training, and audits/inspections to support both… more
- Actalent (Frederick, MD)
- …Operations and CRO teams. * Supports the implementation and management of the Pharmacovigilance (PV) Quality Management System (QMS) and PV System for clinical and ... and systems. * Ensures ongoing qualification of GCP, GLP, and Good Pharmacovigilance Practice (GVP) vendors and systems. * Prepares and negotiates Quality Agreements… more
- Astrix Technology (Monmouth County, NJ)
- …across various industries. We're seeking talented Medical Writers with experience in pharmacovigilance to join us! Our partners range from emerging biotech firms to ... on-site throughout the country! **Responsibilities:** + Prepare and review pharmacovigilance documents including: + Periodic Safety Update Reports (PSURs/PBRERs) +… more
- Ascendis Pharma (Palo Alto, CA)
- …Management Leads working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for managerial oversight ... + Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners /… more
- Ascendis Pharma (Palo Alto, CA)
- …the assigned Vendor Management activities in Ascendis. Key Responsibilities Pharmacovigilance related responsibilities over GVP, Patient Support Programs (PSPs) and ... + Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners /… more
- Ascendis Pharma (Palo Alto, CA)
- …. Assists Head of GPS Medical Science for patient safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations ... for signal detection, evaluation and risk management. . Supports Pharmacovigilance Department direction, standards, and processes for supporting safety monitoring… more