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Associate Director, Global Drug Safety and Pharmacovigilance Scientist

  • Genmab
  • 1000København K,Danmark
  • 04/01/2023

Jobbeskrivelse

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. The Role As Associate Director, 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 DMCs as well as colleagues from other Genmab sites. As Associate 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 Lead. Responsibilities Perform safety review of Adverse Event reports for Genmab products Perform ongoing surveillance (including signal detection/evaluation) of safety data from Genmab clinical trials Be the safety contact for other departments and ensure appropriate and timely handling of safety issues Provide safety review and input to various documents including but not limited to: Trial Protocols, eCRFs/CRFs, and TMFs You will also be contributing to the development of other documentation such as: Investigator’s Brochures, Subject Informed Consent, and Development Safety Update Reports Establish and manage external Data monitoring Committees (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 Contribute to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products Contribute to the development and optimization of new tools and process 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 Ensure compliance with regulatory guidelines and internal processes and procedures in order to be prepared for audits and inspections Participate in audit and inspection activities as required Requirements University degree in life sciences (e.g. MSc Pharm., MSc Human Biology) Solid experience (at least 5 years) within clinical trial safety Experience within the field of oncology and monoclonal antibodies is an advantage Good understanding of medical concepts, disease processes, scientific methodology, drug development, and data analysis Project management skills Strong analytical sense and curiosity Can make independent decisions Excellent communication skills in English both written and spoken Moreover, you meet the following personal requirements: High ethical standards, responsible, and organized with an ability to adapt and drive constant change for continuous improvement Strong communicator, team player and good at building professional relations to collaborators and business partners You are proactive and able to prioritize work in a fast paced and changing environment You are result-and goal-oriented and committed to contributing to the overall success of Genmab Thrive in a multicultural environment Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer. At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do. We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability or genetic information. Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website: http://www.genmab.com/privacy/applicants-hr-genmab-a-s/ Scam alert Please be alerted that at the moment a recruitment scam involving Genmab is circulating. The scam involves recruiters on LinkedIn and elsewhere, pretending to be Genmab employees, headhunting candidates, asking for CVs and other personal information. The scam can include asking for payment for interviews or interview preparation. This communication is not coming from Genmab, we encourage people to stay alert and not to respond to these queries.