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- A pharmaceutical consultancy firm in Maryland is seeking an experienced EU-QPPV (Pharmacovigilance Manager) to oversee pharmacovigilance systems and ensure regulatory compliance across European markets. The ideal candidate should have at least 5 years of EU PV experience...Suggested
- ...quality pharmacovigilance and regulatory affairs services. As we continue to grow, we are looking for an experienced and skilled EU-QPPV (Pharmacovigilance Manager) to oversee pharmacovigilance systems for our clients and ensure regulatory compliance across European...SuggestedFull timeWorldwide
- ...measure quality and compliance. Interfaces Case Management Case Reporting Vendor Compliance Points of Contact Client IPV / LSO LOC QPPV 3rd Party Compliance Contacts GRA GCO Education & Experience Requirements Minimum of Bachelor's Degree in relevant discipline (Business...SuggestedImmediate start
$141k - $228.8k
...top scientific and drug development talent. Assure staff align with company policies and procedures. 7‑Understand and support the QPPV role Understanding the roles and responsibilities of the European Union Qualified Person (QPPV). Ensure support is provided to enable...SuggestedFull timeContract workFlexible hoursShift work- ...device vigilance, complaint handling, and post‑market surveillance in addition to drug safety. Qualified Person for Pharmacovigilance (QPPV) designation or equivalent experience. Startup or early‑stage company experience. Certification in pharmacovigilance or drug...SuggestedWork at officeLocal areaImmediate start
- ...inspections Oversee PV deviations and maintain effective quality systems documentation Provide PV training, regulatory updates, and cross-functional compliance support Support EU QPPV, reporting activities, and product complaint oversight #J-18808-Ljbffr Barrington JamesSuggested
- ...activities for BioCryst products and ensure safety labeling adequately reflects emerging post marketing safety profile.* Support the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products.* Provide support to clinical...SuggestedContract workLocal area
$141.6k - $212.4k
...Pharmaceuticals products in Canada and globally. This role will collaborate cross‑functionally (e.g., with the Safety Management Team, QPPV, other functions, Canada affiliate, vendors) and will be responsible for ensuring compliance with risk management processes and...SuggestedContract workWorldwideFlexible hours- ...Strong knowledge of global PV regulations and pharmacovigilance workflows (case processing, signal detection, aggregate reporting, QPPV interactions). Demonstrated experience managing software/technology projects, especially PV or clinical systems (e.g., Argus, ArisG,...SuggestedFull time
- ...our people, because when we do, we deliver more for patients. Roles and Responsibilities Support the Head of Regional PV and EU/UK QPPV and the Regional PV Lead in the harmonization of processes across the regions Support the Head of Regional PV and EU/UK QPPV and the...SuggestedTemporary workWork at officeLocal areaRemote work
- ...Representative (ASR) and Medical Director technical PV learning strategy and curriculum, in partnership with Regional PV Leads, Office of the QPPV and Area PV Product Leads. Works with subject matter advisors to create content. Drives consistent implementation of the learning...SuggestedTemporary workWork at office
$184k - $227k
...operational descriptions of ICSR processes, vendor models, interfaces, metrics, and retained oversight activities. Partner with the QPPV and Deputy QPPV to ensure ICSR operations are appropriately designed, implemented, and documented within the PV system. Identify...SuggestedContract workTemporary workWork at officeLocal areaWork from home- ...requested data and information for the PSMF, Quality Management Reviews, Annual Reports and other reports and presentations Provide EU QPPV with necessary QA data allowing oversight of the PV quality system Oversight of PV compliance metrics and perform trending, where...SuggestedWorldwide
$220k - $394k
...safety profile to senior management and recommend pharmacovigilance / risk management activities to BI decision making bodies and the EU QPPV. Represent PSPV in internal and external committees & bodies. Contribute to the further development of pharmacovigilance within BI...Suggested- ...actions and preventive measures. Understand the roles and responsibilities of the European Union Qualified Person for Pharmacovigilance (QPPV) and provide support to enable the QPPV to fulfil legal responsibilities. Maintain up-to-date knowledge of medical guidelines,...SuggestedShift work
$180k - $195k
...inspections or internal quality audits in coordination with GCP and PV Compliance teams. Work with Vendor Management, Study Management, QPPV Office, and Medical Safety Science teams for assigned activities. Coordinate US Risk Management Plan implementations and related...Temporary workWork at officeLocal areaFlexible hours- ...Tätigkeiten: Unterstützung der Leitung PV Quality & Partner Management sowie der Stufenplanbeauftragten Medizin / Qualität / EU-/UK-QPPV bei der Terminüberwachung und -koordination, Meetingorganisation, Büroorganisation; Erstellung von Präsentationen Mithilfe bei der...Temporary workRemote work
$156k - $228.8k
...with relevant global or local regulations and organizational compliance with training requirements. Understand and Support of the EU QPPV role Understanding the roles and responsibilities of the EU Qualified Person. Ensure support is provided to enable the Qualified...Full timeLocal areaFlexible hours- ...interactions and projects with other business functions. They will also get an opportunity to interact with other Country Safety Heads and QPPV offices to learn about their roles. Main Responsibilities: The intern will work with the safety data management team. This...Full timeInternshipWorldwideMonday to Friday
$180k - $195k
...and responses to health authorities. Collaborate acrossGlobal Regulatory Affairs,Clinical Development, Medical Affairs, Commercial, QPPV Office, Study Management, Vendor Management, Medical Safety Science, and PV IT on safety processes and system enhancements....Temporary workWork at officeLocal areaImmediate startWorldwideFlexible hoursShift work- ...documentation as needed to support safety labeling updates to adequately reflect emerging postmarketing safety profile. Supports the EU QPPV or other regional/local QP for safety issues on assigned products. Risk Management Planning & Execution: Creates strategy...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work
$265k - $331k
...with safety requirements related to safety science processes. Work with the EU Qualified Person Responsible for Pharmacovigilance (EU-QPPV) to ensure European compliance as applicable. Responsible for ensuring inspection readiness for global inspections by ensuring all...Full timeContract workLocal area- ...customers worldwide. This role oversees the global pharmacovigilance organization, supports the Qualified Person for Pharmacovigilance (QPPV), and partners closely with Regulatory Affairs, R&D, Commercial, Quality, and external stakeholders to safeguard Elanco's global...Full timeLocal areaWorldwide
- ...the successful coordination of contracted PV services—including case processing, safety writing, signal detection, safety reporting, QPPV services, and more—ensuring quality, compliance, financial stewardship, and client satisfaction. As the primary client point of...Remote jobFull timeWork at office
$205k - $245k
...Local Pharmacovigilance and also having a functional link with the European Economic Area Qualified Person for Pharmacovigilance (EEA QPPV - dotted line reporting). The LPV Director (deputy local person responsible for pharmacovigilance) is responsible for maintaining an...Full timeTemporary workWork at officeLocal areaFlexible hours$191.25k - $247.5k
...requires strong collaboration with cross-functional stakeholders, including R&D Quality Business Partners (QBPs), Patient Safety, and QPPV. The Director will work with stakeholders to proactively identify, evaluate, and mitigate pharmacovigilance compliance risks. In...Full timeContract workFor contractorsLocal area$154k - $187k
...designated Sections and Annexes within the BMS Pharmacovigilance System Master File (PSMF). Collaborate with the Head of PSMF, EEA QPPV, and key pharmacovigilance stakeholders to ensure consistent oversight of the BMS Pharmacovigilance System, supporting EEA QPPV...Full timeLive inWork at officeLocal areaRemote workShift work