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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
$156k - $234k
...Medical Affairs, Clinical Operations and Commercial. In 2025 Genmab became MAH in EU hence PSMF deliverables and collaboration with the QPPV are essential. Responsibilities Plan, conduct, report, and follow up on quality audits within GVP-regulated areas Mentor and onboard...SuggestedFull timeFixed term contractWork at officeRemote work- ...partners, to ensure alignment on safety expectations and deliverables.Provide medical support and coverage to non-medically qualified QPPV, deputy QPPV, or other pharmacovigilance colleagues as needed.Mentor and provide guidance to pharmacovigilance team members and...SuggestedTemporary workWork at officeLocal areaImmediate startRemote work3 days per week
$140.8k - $190.49k
...for safety-related regulatory activitiesProvide safety contents for filingsInspection ReadinessUndertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readinessBe representative and point of contact for...SuggestedFull timeRemote workFlexible hours- ...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
- ...in life sciences, pharmacy, nursing, medicine, or related fields (PharmD, MD, MSc, or equivalent). ~ Experience in clinical development safety, post-marketing surveillance, QPPV/deputy QPPV roles, safety committees, or AI-assisted safety review tools is a plus....SuggestedRemote jobFor contractors
YO AI Labs
Dallas, TX13 days ago $238k - $374k
...innovation, continuous learning, and patient-centricity across the PV Operations organization.Collaborate closely with PSPV leadership, QPPV, Regulatory Affairs, Quality, Clinical Development, Medical Affairs, DQS, and other cross-functional stakeholders to align...SuggestedMinimum wageTemporary workLocal area$60 - $69.09 per hour
...as necessary as defined in SOPs or as requested by his/her supervisor Inspection Readiness Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health...SuggestedHourly payContract workTemporary workWork experience placementLocal areaRemote workWorldwide$280k
...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 by...Suggested$298k - $350.6k
...and post-marketing programs. Operate as a peer functional leader alongside the Head of Safety Science, Head of Safety Operations, and QPPV(s) within the Patient Safety & Pharmacovigilance organization, partnering to provide strategic leadership, ensure effective...SuggestedFull time- ..., including leadership messaging, all-staff presentations, and business performance updates. Undertake activities delegated by the QPPV as detailed in the PV System Master File and support ongoing inspection readiness, as applicable. Knowledge and Skills Strong business...SuggestedWorldwideFlexible hours
$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...SuggestedFull timeContract workLocal area- ...team; Post Market Quality Assurance function leadership team; Global Patient Safety / Pharmacovigilance organization (including the EU QPPV office); Regulatory Affairs and Commercial Quality functions; OUS affiliates and regional safety and quality leads; Outsourced third...SuggestedWork at officeLocal area
$260k - $353.6k
...database governance, and vendor oversight. Lead or support European and global launch readiness activities for PV/GVP, including PSMF and QPPV interface, local safety contact readiness, safety data exchange agreements, literature monitoring, medical information/product...SuggestedLocal area$166.5k - $203.5k
...the seamless coordination with cross-functional leaders (e.g., Clinical Operations, Regulatory Affairs, Quality Assurance, and the QPPV Office) to gather accurate, timely data inputs.Responsible for ensuring the PSMF is perpetually ready for health authority inspections...Minimum wageFull timeWork at officeLocal areaFlexible hours$196k - $342.7k
...Minimization (GSSRM), the Chief Safety Officer (CSO), the Chief Medical Officer (CMO) JJ IM, the Qualified Person for Pharmacovigilance (QPPV) JJ IM, other JJ IM R&D leaders and the other groups within GMS to proactively assess, respond and communicate safety concerns for...Local area- ...the GPS Quality Management System, ensuring compliance with global regulatory requirements. Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Support Health Authority Inspection, Business...Remote workFlexible hours
- ...project issues to project team members and department management in a timely manner; Communicate regular monthly updates to the EU QPPV/designee & complete regulatory reports as required. Support pharmacovigilance operations as required. MINIMUM REQUIRED...Work at officeLocal areaWork from home
- ...strategy across the product lifecycle. The Medical Director will serve as a key partner to the Qualified Person for Pharmacovigilance (QPPV), ensuring alignment across global and EU pharmacovigilance obligations, and will provide expert guidance to executive leadership on...Full timeLocal area
- ...GRMSS medical representative for joint clinical development programs with external partners as required. In the absence of the EU/UK QPPV, the GRMSS physician (or their backup) is responsible for responding to product‑related queries as delegated by the EU/UK QPPV....Work experience placementLocal area
$270k - $320k
...PSMF) to support European filings and regulations as applicable. Work with the EU Qualified Person Responsible for Pharmacovigilance (QPPV) to ensure European compliance as applicable. Author, review, and approve pharmacovigilance agreements (PVAs), and safety data...Full timeContract workLocal areaAssociate Director, Patient Safety Scientist Madison - Giralda - NJ - US + 1 more R1604395 Post[...]
$150.3k - $182.13k
...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* Responsible for creation and...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$166.5k - $203.5k
...the seamless c oordination with cross-functional leaders (e.g., Clinical Operations, Regulatory Affairs, Quality Assurance, and the QPPV Office) to gather accurate, timely data inputs. Responsible for ensuring the PSMF is perpetually ready for health authority...Minimum wageFull timeWork at officeLocal areaFlexible hours$70 - $80 per hour
...medicine (for example PharmD, MD, MSc, or equivalent). Desirable experience: development-stage and post-marketing safety reporting, QPPV or deputy QPPV responsibilities, participation in safety committees, or familiarity with AI-assisted safety review tools. Work...Remote jobHourly payFor contractorsSaidGig
Remote5 days ago
