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$138.5K

How much do eu qppv jobs pay per year?

As of Jul 15, 2026, the average yearly pay for eu qppv in the United States is $95,411.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $112,000.00 per year, depending on experience, location, and employer.

Which country is best for pharmacovigilance?

For a Eu QPPV, countries with strong pharmaceutical industries and robust regulatory agencies, such as Germany, France, and the UK, offer significant opportunities in pharmacovigilance. These countries often have well-established pharmacovigilance frameworks, requiring expertise in safety data analysis, compliance, and relevant certifications like PV training or GVP knowledge. Job prospects are also influenced by the presence of multinational pharmaceutical companies and regulatory authorities.

What are the key skills and qualifications needed to thrive as an EU QPPV (Qualified Person for Pharmacovigilance), and why are they important?

To thrive as an EU QPPV, you need a strong background in pharmacy, medicine, or life sciences, with in-depth knowledge of pharmacovigilance regulations and relevant EU legislation. Familiarity with safety databases, signal detection tools, and compliance management systems, along with training such as Good Pharmacovigilance Practice (GVP) certification, is typically required. Excellent leadership, communication, and problem-solving skills set outstanding QPPVs apart, as they must coordinate teams and interact with regulatory authorities. These competencies ensure effective oversight of drug safety, regulatory compliance, and protection of patient health.

What are some of the main challenges faced by a EU QPPV, and how can they be managed effectively?

One of the main challenges for a EU QPPV (Qualified Person Responsible for Pharmacovigilance) is ensuring ongoing compliance with ever-evolving pharmacovigilance regulations across the EU. This often involves staying up to date with legislative changes, managing large volumes of safety data, and effectively coordinating with global and local teams. To manage these challenges, strong organizational skills, regular training, and robust communication channels with internal stakeholders are crucial. Many QPPVs also rely on supportive technologies and external networks to streamline workflows and maintain compliance.

What is an EU QPPV?

An EU QPPV, or European Union Qualified Person Responsible for Pharmacovigilance, is a legally mandated role required for pharmaceutical companies marketing medicines in the EU and UK. The QPPV is responsible for ensuring that the company's pharmacovigilance system complies with regulatory requirements, monitoring the safety of medicines, and acting as the main contact point for health authorities. This role involves oversight of adverse event reporting, risk management, and ensuring that appropriate measures are in place to protect patient safety.

Will AI replace pharmacovigilance jobs?

AI can assist pharmacovigilance professionals, including Eu QPPV, by automating data analysis and signal detection, but it is unlikely to fully replace these roles due to the need for expert judgment, regulatory understanding, and decision-making. Human oversight remains essential for interpreting complex safety data and ensuring compliance. Pharmacovigilance jobs will evolve to incorporate AI tools, emphasizing skills in data management and regulatory knowledge.

What are the qualifications for a QPPV?

A QPPV (Qualified Person Responsible for Pharmacovigilance) typically requires a university degree in pharmacy, medicine, or a related field, along with extensive experience in pharmacovigilance or drug safety. Certification in pharmacovigilance or regulatory affairs is often preferred, and the role demands strong knowledge of regulatory requirements and good communication skills.

What is a QPPV in the EU?

A QPPV (Qualified Person Responsible for Pharmacovigilance) in the EU is a designated individual responsible for overseeing the safety of medicinal products, ensuring compliance with pharmacovigilance regulations. They typically have extensive experience in drug safety, regulatory affairs, and pharmacovigilance systems, and are often supported by pharmacovigilance teams within pharmaceutical companies. The QPPV must be based in the EU and is required to maintain continuous oversight of safety data and reporting obligations.
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Infographic showing various Eu Qppv job openings in the United States as of July 2026, with employment types broken down into 83% Full Time, 11% Part Time, 1% Temporary, 4% Contract, and 1% Nights. Highlights an 86% Physical, 4% Hybrid, and 10% Remote job distribution, with an average salary of $95,411 per year, or $45.9 per hour.
Senior / Executive Director, Clinical Quality Assurance

Senior / Executive Director, Clinical Quality Assurance

Immunome, Inc.

Bothell, WA

Other

Posted 4 days ago

Job description

Position Overview 

Immunome is seeking a highly experienced and strategic Senior / Executive Director, Clinical Quality Assurance to lead and implement global clinical quality strategies supporting Immunome's oncology portfolio. This role will provide quality leadership across clinical development, clinical operations, pharmacovigilance/drug safety, nonclinical and translational partners, data management, regulatory affairs, and external vendors. 

The successful candidate will bring deep expertise in GCP, GLP/GCLP, and GVP/GPV expectations, global inspection readiness, outsourced development oversight, and fit-for-purpose quality systems. This position offers a highly visible leadership opportunity to scale Immunome's clinical quality capabilities, ensure patient safety and data integrity, and support high-quality execution from clinical development through regulatory submission, launch readiness, and post-marketing commitments. 

Responsibilities 

Clinical Quality Strategy and Governance 

  • Develop and implement a risk-based Clinical QA strategy across GCP, GLP/GCLP, and GVP/GPV activities aligned with Immunome's pipeline, corporate objectives, and global development plans. 
  • Serve as a senior quality leader and subject matter expert for clinical quality matters, including quality risk management, inspection readiness, regulatory intelligence, issue escalation, and quality governance. 
  • Establish clear roles, responsibilities, escalation pathways, quality metrics, and decision-making forums across internal teams, vendors, partners, affiliates, and consultants. 
  • Represent Clinical QA on R&D governance forums, program teams, safety governance forums, quality councils, launch readiness teams, and regulatory inspection teams. 

Clinical Trial and Development Oversight 

  • Provide strategic and hands-on QA oversight for global clinical trials from protocol development and study start-up through conduct, closeout, clinical study reports, regulatory submissions, and inspections. 
  • Partner with Clinical Operations, Clinical Development, Medical Affairs, Biostatistics, Data Management, Regulatory Affairs, and CROs to embed quality into study design, monitoring strategy, data flow, protocol deviation management, and trial documentation. 
  • Ensure clinical trials are conducted, documented, and reported in compliance with applicable regulations, ICH GCP, study protocols, informed consent requirements, Immunome SOPs, and quality agreements. 
  • Oversee clinical quality activities, including site audits, CRO oversight, eTMF quality, protocol deviations, serious breach assessments, nonconformances, root cause analysis, CAPA development, and CAPA effectiveness. 

PV/GVP and Launch Readiness 

  • Provide QA oversight of pharmacovigilance and drug safety systems across clinical development and post-marketing activities, including safety case intake, processing, medical review, expedited reporting, aggregate reporting, signal management, safety 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 complaint reconciliation, and regulatory inspection preparedness. 
  • Partner with Drug Safety, Regulatory Affairs, Medical Affairs, Commercial, Legal/Privacy, Technical Operations, Supply Chain, and external partners to ensure launch-related quality activities are appropriately documented, trained, governed, and inspection-ready. 

Audit, Inspection, and Vendor Quality Management 

  • Design and execute a risk-based audit strategy for clinical sites, CROs, central and specialty laboratories, PV vendors, computerized systems, internal processes, affiliates, and partner organizations. 
  • Identify, qualify, and oversee external vendors and partners to ensure high-quality, timely, compliant execution and clear sponsor oversight across highly outsourced development activities. 
  • Lead periodic quality reviews with critical vendors to evaluate metrics, audit findings, inspection history, deviations, CAPAs, service issues, data integrity risks, and continuous improvement opportunities. 
  • Prepare Immunome and external partners for global health authority inspections, including FDA, EMA, EU Member State, MHRA, PMDA, Health Canada, and other applicable regulatory authorities. 

Quality Systems, CAPA, and Continuous Improvement 

  • Own or co-own Clinical QA processes within the QMS, including SOPs, audit management, deviations/nonconformances, CAPAs, change control, training, document management, vendor qualification, quality agreements, and management review. 
  • Define and monitor quality metrics, dashboards, risk logs, quality signals, issue trends, audit trends, inspection trends, CAPA effectiveness, vendor quality performance, and inspection readiness status. 
  • Provide QA oversight of regulated computerized systems and records used in clinical development and PV, including eQMS, LMS, DMS, eTMF, EDC, CTMS, RTSM/IWRS, statistical programming tools, data warehouses, and safety databases. 
  • Drive continuous improvement by using audit outcomes, inspection intelligence, regulatory intelligence, metrics, and benchmarking to strengthen policies, systems, training, and operational execution. 

Leadership and Collaboration 

  • Build, lead, coach, and develop a high-performing Clinical QA team and/or network of consultants and outsourced auditors, establishing clear objectives, priorities, accountability, and development plans. 
  • Set expectations for pragmatic, risk-based, business-facing QA support that enables speed, quality, patient safety, data integrity, and regulatory trust. 
  • Manage department budgets, audit/vendor resources, consultant engagements, and capacity planning in alignment with pipeline, launch, and inspection priorities. 
  • Promote a culture of transparency, collaboration, continuous learning, and quality ownership across R&D, PV, Medical, Regulatory, Technical Operations, Commercial, and external partners. 

Qualifications 

  • Bachelor's degree in life sciences, pharmacy, nursing, biochemistry, chemistry, biotechnology, or a related field required; advanced degree (MS, PharmD, PhD, MPH, or equivalent) preferred. 
  • 12+ years of progressive quality assurance, compliance, clinical operations, drug safety, regulatory, or development experience in biotechnology/pharmaceuticals for Senior Director level; 15+ years for Executive Director level, or equivalent experience. 
  • Significant leadership experience in GCP, GLP/GCLP, and/or GVP/GPV quality oversight in a regulated clinical development environment. 
  • Demonstrated success establishing, scaling, or maturing quality systems, audit programs, vendor oversight programs, CAPA programs, inspection readiness programs, and quality metrics in an outsourced or hybrid operating model. 
  • Proven experience leading or supporting global regulatory inspections, including direct interaction with health authorities and management of inspection responses, commitments, and follow-up activities. 
  • Experience supporting clinical development, regulatory submissions, and product lifecycle milestones such as INDs, CTAs, NDA/BLA/MAA submissions, approvals, launch readiness, and post-authorization obligations. 
  • Strong knowledge of clinical trial operations, data integrity, eTMF, EDC, CTMS, safety databases, computerized system validation/assurance, Part 11, and Annex 11 expectations. 
  • Oncology, ADC, biologics, immuno-oncology, or other complex therapeutic modality experience preferred. 
  • Direct experience with European product launch, EU pharmacovigilance system readiness, QPPV/PSMF governance, local safety contacts, affiliate/distributor oversight, or EU PV inspections preferred. 

Knowledge and Skills 

  • Deep knowledge of global clinical quality and pharmacovigilance requirements, including ICH GCP, FDA GCP/GLP/PV-related regulations, EU Clinical Trials Regulation, EU GVP modules, OECD GLP principles, MHRA expectations, and other applicable regional requirements. 
  • Strong strategic quality leadership skills, with the ability to set vision, governance, metrics, priorities, and risk-based operating models while remaining close enough to the work to resolve critical issues. 
  • Proven inspection leadership capabilities, including preparing teams, managing inspection logistics, coaching SMEs, triaging requests, supporting front-room/back-room processes, leading responses, and closing commitments. 
  • Demonstrated ability to influence executives, cross-functional leaders, vendors, and partners while balancing regulatory rigor with pragmatic, phase-appropriate implementation. 
  • Excellent written and verbal communication skills, with the ability to simplify complex quality and regulatory issues for senior leadership, auditors, inspectors, and cross-functional teams. 
  • Strong project management, organizational, analytical, and problem-solving skills with the ability to manage multiple priorities in a fast-paced, dynamic biotech environment. 
  • Demonstrated success building teams, developing talent, managing external experts, and creating a practical quality culture that enables compliant execution. 

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