Director, Global Drug Safety & Pharmacovigilance Physician

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

As a Lead Safety Physician, you will be responsible for guiding the safety strategy and operations for Genmab’s development and marketed products. You will play a key role in both pre- and post-marketing safety activities, contribute to cross-functional initiatives, and help grow the Global Drug Safety & Pharmacovigilance (GDS&PV) department, and ultimately our company. Your contribution will help ensure the highest standards of safety assessment, risk management, and regulatory compliance, directly supporting Genmab’s mission to improve the lives of patients impacted by cancer.

Responsibilities

• Lead all major safety-related activities for assigned products, both in development and post-marketing, including:
  Signal detection and evaluation;
  Benefit-risk assessments;
  Risk management planning and execution;
   

• Collaborate cross-functionally and within drug safety teams to:
  Review adverse events (AEs) and scientific literature;
  Perform safety surveillance and communicate findings effectively;
  Oversee identification, management, and mitigation of safety issues; propose systemic solutions;
   

• Contribute to safety sections of key clinical and regulatory documents such as:
  Trial protocols and amendments;
  Clinical trial reports (CTRs);
  eCRFs/CRFs and Trial Master Files (TMFs);
   

• Prepare safety documentation per regulatory requirements, including:
  Benefit-risk sections of aggregate reports;
  Safety summaries;
   

• Lead and manage safety-related forums such as:
  External Data Monitoring Committees (DMCs);
  Genmab Safety Committees;
   

• Provide training, oversight, and guidance on safety and PV processes to internal and external stakeholders, including:
  Genmab employees;
  Contract Research Organizations (CROs);
  Investigators;
   

• Actively engage with:
  Internal stakeholders (e.g. multidisciplinary project teams);
  External experts, partners, and regulatory authorities (including audit and inspection readiness);
   

• Train and mentor teams on emerging safety topics, PV technologies, and global regulations;
   

• Perform medical review causality assessment of individual cases of products in development as marketed (e.g.: SUSARs)
   

• Review adverse events (AEs) and scientific literature.

Requirements

• Medical degree (MD) required;
   

• At least 12 years of experience in drug safety/pharmacovigilance across clinical development and post-marketing, ideally in oncology;
   

• Filing experience is a pre;
   

• Demonstrated experience with:

  Regulatory authority inspections and PV audits;
  Collaboration with the FDA and other global regulatory bodies;
  Global pharmacovigilance regulations (e.g. GVP and GCP), initiatives, and standards;
   

• Proficiency with:

  MedDRA and WHODrug coding dictionaries;
  Individual case processing, triage, and medical review;
  Safety databases (e.g. ARGUS) and electronic data capture systems;
   

• Strong leadership and mentoring experience;
   

• You bring team builder skills and are a true team player.
   

• Proven success in a similar or equivalent role.

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds