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!

Director, Global Drug Safety & Pharmacovigilance Compliance

The Role

Establishing a US-based Pharmacovigilance (PV) Compliance Director position will strengthen global compliance capabilities, provide essential support across multiple time zones, improve responsiveness to audits and inspections, and ensure consistent compliance oversight for GDS&PV's global development and post-marketing activities.

Responsibilities

Ensure appropriate establishment and execution of all global pharmacovigilance procedures working closely with global colleagues from other departments/regions as applicable.

Support with overseeing and maintaining global pharmacovigilance policies, procedures, and workflows, including development and implementation of SOPs and other controlled documents support with investigational and marketed product safety surveillance.

Work arrangement: This role offers flexibility to work away from the office for 20%–40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager.

Responsibilities

✓Act as the lead US for PV audits and inspections, overseeing preparation, conduct, responses, and post-audit/inspection actions:
✓Coordinate and support GDS&PV preparation activities for internal audits, partner audits, and health authority inspections.
✓Maintain audit and inspection trackers, action lists, and timelines.
✓Support scheduling of audit/inspection meetings, interviews, training and readiness activities.
✓Coordinate collection, organization, and version control of requested documentation.
✓Track and follow up on audit/inspection actions and commitments in collaboration with GDS&PV compliance and process owners and cross-functionally.
✓Coordinate and support Quality Events creation, follow-up, and timely closure.
✓Support inspection readiness activities (e.g. quarterly internal compliance health checks on key PV processes, evidence repositories, story boards, trackers, lessons learned).
✓Manage and oversee the GDS&PV Quality Event process resulted from continuous compliance monitoring and work closely with Global QA to address and document responses and provide feedback to ensure adherence to the internal and external guidance documents, and SOPs.
✓Co-representing Global GDS&PV Compliance in relevant end-to-end process execution activities and governance forums. Governance and Oversight
✓Work with the other GDS&PV Compliance teams to ensure that safety/PV training is provided to all relevant global internal and external employees and 3rd parties.
✓Ensure compliance with regulatory authority guidelines and regulations as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations.
✓Provide support to the global GDS&PV team with compliance oversight relevant to the regions in compliance with current regional regulations, internal and external guidance documents, and SOPs

Requirements

✓Advanced degree in healthcare related field
✓Minimum requirement: 12+ years of relevant experience in Pharmacovigilance/Clinical Research
✓Significant experience managing and leading processes/projects in own area (e.g. guidance documents as per intl. regulations & reporting requirements; preparation of post-marketing spontaneous and clinical trial safety assessments; regulatory submissions; safety case processing; PV data systems; safety data base systems and the report generation)
✓Experience working with FDA/EMA/PMDA/ICH requirements, good clinical practices, pharmaceutical clinical development and PV audits and inspections during clinical through to and beyond post marketing
✓Experience training and mentoring team members, and communicating effectively with internal and external stakeholders

Proven performance in earlier role/comparable role

For US based candidates, the proposed salary band for this position is as follows:

$197,840.00---$296,760.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:

✓401(k) Plan: 100% match on the first 6% of contributions
✓Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
✓Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
✓Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
✓Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
✓Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

Further details on eligibility for compensation and benefits based on 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.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.