(Associate) Director, Global Drug Safety

Gevonden in: Talent NL C2 - 2 weken geleden

Utrecht, Nederland Genmab Voltijd

The Role

& Department


The Drug Safety & Pharmacovigilance (GDS&PV) Physician role is a safety expert medical role contributing to the global safety strategy and overall safety profile for the assigned Genmab products (mainly investigational) throughout their lifecycle.

As our AD/Director, you must effectively interact cross-functionally at all levels in the organization, as well as with external parties, including Regulatory Authorities, as applicable. The role reports to the Senior Director MD, Team Lead.

You will work together with other Drug Safety staff in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports, and communicating changes in the product risk profile to internal and external stakeholders supporting the Team Lead. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

This position has a global perspective, and you will interact with stakeholders ranging from regulatory authorities and Data Monitoring Committees as well as colleagues from other Genmab sites. As AD/Director, GDS&PV Physician, you will be part of a highly skilled and international team and you will act as a GDS&PV ambassador cross company- e.g., by explaining and training on PV principles. Importantly, you are also expected to mentor more junior colleagues, and help them reach their best.

Key responsibilities include

  • Lead all major pre- and post-marketing safety-related activities including signal identification and assessment, benefit-risk evaluation and risk management activities for own area 

  • Effectively collaborate with drug safety and cross-functional teams for safety assessments (e.g., review of AEs/SAEs and scientific literature; safety reports), ongoing surveillance, and related communication around assigned Genmab products

  • Oversee handling of safety issues and implementing risk mitigation activities

  • Provide inputs to different documents (e.g. trial protocols, amendments and plans; clinical trial reports; eCRFs;TMFs) based on review

  • Prepare relevant documentation (e.g., benefit/risk sections of aggregate reports; safety summaries) and Q&As as per regulatory requirements 

  • Manage internal & external forums (e.g., external Data Monitoring Committees; Genmab Safety Committees) for assigned products

  • Provide guidance, oversight, and training around safety to relevant stakeholders (e.g. Genmab employees, CROs, Investigators)

  • Proactively engage with internal stakeholders (e.g. multidisciplinary project groups) and external stakeholders (e.g. external experts, partners, regulatory authorities)

  • Take part in audits and inspections

  • Train and mentor teams on emerging safety aspects and PV processes/technologies/regulations

Requirements

  • Medical Doctor degree required

  • Minimum requirement: 12+ years’ experience in in drug safety/pharmacovigilance covering both clinical development and post-marketing

  • Solid clinical judgement: experience in oncology is a plus

  • Experience with PV audits/ Regulatory Authority Inspections and worldwide regulatory authorities’ interactions

  • Experience with global PV regulatory environment (regulations, initiatives, standards, GVP); MedDRA and WHODrug coding dictionaries

  • Experienced in individual adverse event case report processing, triage, and medical review

  • Experience with safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems preferred

  • Experience guiding and mentoring team members

  • Proven performance in earlier role/comparable role

Furthermore, you meet the following personal requirements:

  • Self-driven learner, pragmatic, problem solver, and curious

  • Team player, focused on the overall success of the team, the project, and Genmab

  • Strong communicator and good at building professional relations to colleagues, collaborators, and business partners

  • Proactive and able to prioritize work in a fast paced and changing environment

  • Result-and goal-oriented

  • Able to express own opinion with supporting arguments and facts

  • Thrive in a multicultural environment

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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