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Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU and UK (homebased) (Fully Remote
Establish and maintain a system for collecting all suspected adverse reactions. Ensure authorities' requests for benefit-risk information are answered fully and promptly. Oversee product safety profiles and emerging safety concerns. Qualifications: Life-science education...SuggestedRemote job$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- ...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 $183.1k - $305.2k
...inspection readiness programs. This role partners closely with the Senior Director, GPS leadership, Global Development Quality, and the QPPV Office, and operates as a functional leader who coordinates and delegates work across the team to ensure consistent, high-quality...SuggestedWork at officeWorldwide- ...GSSRM), the Chief Safety Officer (CSO), the Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory...SuggestedFor contractorsLocal area
$265k - $397.4k
...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...Suggested$140.8k - $190.49k
...of 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...SuggestedRemote 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 EDUCATION...SuggestedWork at officeLocal areaWork from home
$243k - $356.4k
...research scientists, and pharmacoepidemiologists. Assures staff comply with company policies and procedures Understand and support the QPPV role: Understanding the roles and responsibilities of the European Union Qualified Person (QPPV). Ensure support is provided to...SuggestedFull timeFlexible hoursShift work- ...(KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), Business development...SuggestedFull timeLocal areaImmediate startWorldwideFlexible hours
- ...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....SuggestedWork experience placementLocal area
$227.9k - $308.3k
...capabilities in a matrixed environment. ~ Proven experience with risk-based GVP audits and health-authority inspections, including QPPV and PSMF-related scope. ~ Executive presence and demonstrated ability to align operational, embedded compliance, and independent...SuggestedFull timeTemporary workLocal areaRemote workFlexible hours- ...diverse audiences. Preferred Experience building or significantly scaling a PV function at a clinical-stage company. QPPV designation or experience supporting QPPV responsibilities in the EU. Familiarity with safety considerations in Phase 3 global...SuggestedRemote workFlexible hours
Immuneering Corporation
United States4 days ago - ...Indicators (KPI) and monthly metrics reports, as needed. Supports Qualified Person Responsible for Pharmacovigilance in Europe (EU QPPV) and local QPPV(s) in his/her activities throughout the project. Prepares project specific presentations for client meetings/...SuggestedContract workTemporary workFixed term contractLocal areaRemote workFlexible hours
$171k - $299.2k
...retain top scientific and drug development talent. Assure staff comply with company policies and procedures. Understand and support the QPPV role Understanding the roles and responsibilities of the European Union Qualified Person (QPPV). Ensure support is provided to...SuggestedFull timeContract workFlexible hoursShift workBioSpace, Inc.
Indianapolis, IN1 day ago- ...related to operational activities. Ensure governance of operational KPIs, quality metrics and compliance monitoring. Collaborate with QPPV Office, Medical/Clinical Safety, PV/MI Technologies, and Medical Information functions to ensure harmonized PV/MI governance....Work at officeRemote work
Biomapas Group
New York, NY1 day ago - ...safety-related regulatory activities, Provide safety contents for filings - 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...Flexible hours
Amgen SA
New York, NY4 days ago $365k
...global markets. The incumbent will provide leadership and oversight of the entire DSPV organization, including Medical Safety, EMEA QPPV operations, Japan PV operations, and DSPV Operational Excellence and Compliance functions. A key priority for this leader is the...Full timeWork at officeLocal areaRemote workFlexible hours$222k - $303k
...aggregation and evaluation of compliance information across the PV system, the role supports both the Head of Pharmacovigilance and the EU/UK QPPV in maintaining effective oversight of the PV system and driving continuous improvement. This individual will be a key member of the...Full timeWork at officeLocal areaRemote workFlexible hours$124.5k - $182.6k
...integration of pharmacovigilance capabilities, and represents the region in GPS-level governance and strategy. While holding a Local QPPV / responsible person nomination is not a core expectation of this role, where the role holder meets the residency, language and...Full timeLocal areaFlexible hoursEli Lilly and Company
Indianapolis, IN2 days ago$146.05k - $176.98k
...support safety labeling updates to ensure labeling adequately reflects the 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 the...Hourly payFull timeSummer workLive inLocal areaRemote workFlexible hoursShift work$110 - $117 per hour
...processes to ensure training and compliance with processes are maintained. Leads interactions with other PSPV functions including EU QPPV and Global Medical Safety to ensure processes are regularly updated and are fit for purpose. Leads interactions and oversight of...Contract work
