Vice President, Global Qualified Person for Pharmacovigilance (Global QPPV)

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role

The VP, Global QPPV is responsible for oversight of the Genmab global pharmacovigilance (PV) system and serves as the statutory EU Qualified Person for Pharmacovigilance (QPPV). The role operates within a distributed Model PV organization, with central governance through the QPPV Office and execution through Affiliate PV Oversight (APVO) and local PV structures.

This role offers a unique blend of strategic leadership and hands-on execution in a biotech environment characterized by agility, innovation, and scientific depth.

Responsibilities

Establishing and maintaining oversight of the global PV system

• Ensure that an effective and robust pharmacovigilance system is in place in compliance with applicable global regulatory requirements (EU, FDA, ICH, and other regions)

• Oversee processes for:

- Collection, assessment, and reporting of adverse events

- Signal detection and management

- Aggregate reporting (PSUR/PBRER, DSUR)

- Risk management activities

• Ensure the PV system is inspection-ready at all times

EU QPPV responsibilities

• Serve as the EU QPPV and fulfill all regulatory obligations

• Maintain and approve the Pharmacovigilance System Master File (PSMF)

• Ensure the PSMF is available to competent authorities upon request

• Act as primary contact with EMA and EU/EEA regulatory authorities

• Ensure timely and accurate responses to health authority requests

Leadership of the QPPV Office:

• Establish and maintain the QPPV Office as the central governance function for PV

• Define standards and frameworks for:

- Global and local QPPV roles

- Escalation pathways

- PV governance and decision-making

• Provide a forum for alignment, communication, and escalation across local QPPVs

Oversight of Affiliate PV model:

• Provide oversight across:

- Affiliate PV Oversight (APVO)

- Local QPPVs and PV representatives

- Distributors and external partners

• Ensure clear delineation of responsibilities between governance (QPPV Office) and execution (APVO/local PV)

• Maintain visibility over PV compliance and performance across all regions

Collaboration with Affiliate PV Oversight (APVO):

• Partner with APVO to ensure appropriate local PV structures and resourcing

• Support oversight of:

- Local PV compliance

- PV Agreements (PVAs)

- Distributor PV responsibilities

• Ensure effective escalation and resolution of local PV issues

Medical oversight of product safety:

• Maintain oversight of benefit-risk profiles across the product portfolio

• Collaborate with Safety Physicians and Surveillance teams

• Contribute to:

- Signal evaluation and prioritization

- Risk management strategies

- Preparation of regulatory safety reports

Inspection, audit and compliance:

• Support and lead PV inspections by regulatory authorities

• Collaborate with Quality Assurance on PV audit strategy

• Review and approve CAPAs for major and critical findings

• Monitor PV compliance and performance metrics

PV system architecture and scalability:

• Ensure PV infrastructure supports global expansion and product launches

• Oversee alignment of global and local PV requirements

• Provide input into decisions on:

- Outsourcing versus internal resourcing

- Local PV operating models

Deputy QPPV:

• Ensure a suitably qualified Deputy QPPV is appointed

• Maintain continuity of PV oversight, including 24/7 availability

Key Requirements

• Medical Doctor (MD) required

• Extensive experience in pharmacovigilance (15+ years preferred)

• Prior experience as EU QPPV or Deputy QPPV is required on a global level

• Strong understanding of global pharmacovigilance regulations

• Experience managing global and distributed PV systems

• Experience working with affiliates, local PV structures, and distributors

• Proven track record in regulatory inspections

• Ability to influence senior stakeholders across a matrix organization

• Demonstrates strategic agility with a “roll-up-your-sleeves” approach

• Operates effectively a in a dynamic, high-growth biotech environment while maintaining scientific and operational rigor

The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is:

The final salary offer will depend on several factors, including your skills, qualifications, and experience.

In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to:

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

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