Global Oncology Safety Leader

1 month ago


Copenhagen, Copenhagen, Denmark Genmab Full time

Transform the lives of patients through innovative cancer treatments by joining Genmab as a seasoned expert in drug safety and pharmacovigilance.

We're seeking a highly skilled MD with at least 12 years of experience in drug safety/pharmacovigilance, preferably within oncology, to lead critical safety evaluations and risk management activities. Your expertise will navigate the safety of groundbreaking cancer therapies and propel our company forward.

About the Role:

  • Lead all major pre- and post-marketing safety-related activities, including signal, benefit-risk evaluation, and risk management for assigned products
  • Effectively collaborate with cross-functional teams on safety assessments, ongoing surveillance, and related communication around Genmab products
  • Be responsible for handling safety issues and implementing risk mitigation activities, proposing systemic solutions
  • Provide inputs to various documents, such as trial protocols, amendments, and plans, clinical trial reports, eCRFs/CRFs, and TMFs, based on review
  • Prepare relevant documentation, like benefit/risk sections of aggregate reports and safety summaries, as per regulatory requirements
  • Lead internal & external forums, such as Data Monitoring Committees (DMCs) and Genmab Safety Committees, for assigned products
  • Provide guidance, oversight, and training on safety to relevant collaborators, including Genmab employees, CROs, and Investigators
  • Proactively engage with internal team members and external collaborators, such as external experts and partners, around emerging landscapes and regulatory authorities during audits and inspections
  • Train and mentor teams on emerging safety aspects and PV processes, technologies, and regulations

Your Background:

  • You possess an MD with at least 12 years of experience in drug safety/pharmacovigilance, ideally within oncology
  • You have navigated the global PV regulatory landscape and are proficient in audits, inspections, and regulatory authority interactions
  • You are a strategic thinker experienced in safety databases and electronic data capture systems
  • You guide, mentor, and encourage your team towards excellence

About Us

Genmab is committed to building extraordinary futures together by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our agile working environment prioritizes employee work-life balance and fosters collaboration across diverse backgrounds.

Compensation:

The estimated annual salary for this role is $140,000 - $180,000, depending on location and qualifications.



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