Associate Director/Director, Global Drug Safety & Pharmacovigilance Scientist

Associate Director/Director, Global Drug Safety & Pharmacovigilance Scientist

Genmab

Utrecht or Copenhagen

The Role

As an Associate Director/Director, Global Drug Safety and Pharmacovigilance Scientist, you will become part of the Global Drug Safety and Pharmacovigilance department, where you will be responsible for drug related activities in close cooperation with the Safety Physicians. This position has a global perspective and you will interact with stakeholders ranging from regulatory authorities and Data Monitoring Committees (DMCs), as well as colleagues from other Genmab sites.

As an Associate Director/Director, Global Drug Safety and Pharmacovigilance Scientist you will be part of a highly skilled and international team. The position reports to the Project Safety Physician.

This role can be based in either the Netherlands or Denmark.

Responsibilities

  • Perform safety reviews of Adverse Event reports for Genmab products.
  • Perform ongoing surveillance (including signal detection/evaluation) of safety data from Genmab clinical trials together with the safety physician.
  • Be when required primary safety contact for other departments and ensure appropriate and timely handling of safety issues.
  • Provide safety reviews and input for various documents including but not limited to: Trial Protocols, eCRFs/CRFs, and TMFs.
  • Contribute to the development of other documentation such as: Investigator’s Brochures, Subject Informed Consent, and Development Safety Update Reports.
  • Participate in the management of external DMCs for early phase trials.
  • Contribute to the planning and conduct of Safety Committee activities.
  • Conduct safety training of Genmab employees, CROs, Investigators and other relevant site personnel, as necessary.
  • Participate and contribute to multidisciplinary project groups including membership for assigned products.
  • Contribute to the development and optimization of new tools and processes within Drug Safety.
  • Interact with safety and clinical CROs, perform sponsor oversight activities for safety related tasks, process invoices, and ensure regulatory compliance (including regulatory reporting requirements) for assigned products.
  • Oversee Safety Data Exchange Agreements with partners as required.
  • Collaborate with external experts and partners.
  • Support ongoing surveillance of new and updated regulations/guidelines and assess the impact on drug safety processes at Genmab.
  • Ensure compliance with regulatory guidelines and internal processes and procedures in preparation of audits and inspections.
  • Participate in audit and inspection activities as required.

Requirements

  • Registered Nurse, Bachelor of Science in Nursing, Veterinarian, Pharmacist, Master of Science or PhD qualification in a relevant Life Science subject.
  • A minimum of 5 years practical experience within drug safety and/or pharmacovigilance.
  • Experience within first in human or early stage clinical trials.
  • Experience from the field of oncology is advantageous.
  • Documented experience from overseeing multiple trials with safety inputs at the Global level.
  • International experience from a similar role with internal and external stakeholders.
  • Familiar with medical review and individual safety reports.
  • Experience with databases (clinical and safety).
  • Experience of vendor management.
  • Excellent communication skills in English, both written and oral.
  • Strong communication skills and excellent at building professional relationships with collaborators and business partners.
  • A proactive approach and able to prioritize work in a fast paced and changing environment.
  • Result-and goal-oriented and committed to contributing to the overall success of Genmab.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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