(Associate) Director, Global Drug Safety

6 maanden geleden

Utrecht, Nederland Genmab Voltijd

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

About the Role: As the (Associate) Director, Global Drug Safety & Pharmacovigilance Physician at Genmab, where your expertise will navigate the safety of ground-breaking cancer therapies. With a Medical Doctorate and over 12 years in drug safety, ideally in oncology, you will lead critical safety evaluations and risk management activities. Your role involves collaboration with cross-functional teams, leading all aspects of safety issue management, and engaging with regulatory authorities. A profound understanding of global PV regulations, safety databases, and mentorship skills are essential. Propel your career forward by shaping the future of oncology treatments with us.

 

Your Responsibilities:

  • Lead all major pre- and post-marketing safety-related activities including signal, benefit-risk evaluation and risk management activities for own area
  • Effectively collaborate with drug safety and cross-functional teams for safety assessment (e.g. review of AEs and scientific literature; safety reports), ongoing surveillance, and related communication around assigned Genmab products
  • Be responsible for handling of safety issues and implementing risk mitigation activities, and propose systemic solutions 
  • Provide inputs to different documents (e.g. trial protocols, amendments and plans; clinical trial reports; eCRFs/CRFs;TMFs) based on review
  • Prepare relevant documentation (e.g. benefit/risk sections of aggregate reports; safety summaries) as per regulatory requirements 
  • Lead internal & external forums (e.g. external Data monitoring Committees (DMCs); Genmab Safety Committees) for assigned products
  • Provide guidance, oversight, and training around safety to relevant collaborators (e.g. Genmab employees, CROs, Investigators)
  • Proactively engage with internal team members (e.g. multidisciplinary project groups) and external collaborators (e.g. external experts and partners around emerging landscape; regulatory authorities around audits and inspections)
  • Train and mentor teams on emerging safety aspects and PV processes/technologies/regulations

 

Who you are:

  • An MD with at least 12 years of experience in drug safety/pharmacovigilance, ideally within oncology
  • A seasoned navigator of the global PV regulatory landscape, proficient in audits, inspections, and regulatory authority interactions.
  • A strategic thinker with experience in safety databases and electronic data capture systems
  • A leader who guides, mentors, and encourages your team towards excellence.

About You

  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
  • You are a generous collaborator who can work in teams with diverse backgrounds
  • You are determined to do and be your best and take pride in enabling the best work of others on the team
  • You are not afraid to grapple with the unknown and be innovative
  • You have experience working in a fast-growing, dynamic company (or a strong desire to)
  • You work hard and are not afraid to have a little fun while you do so

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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