Drug Safety Lead
|Category:||Global Drug Safety|
Job SummaryAbout us
Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.The role
Genmab is on an ambitious growth path and to support this growth Genmab is looking for an additional Drug Safety Lead to join the team in Copenhagen.
As an Associate Director/Director of Drug Safety, you will become part of the Global Drug Safety department, where you will become 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 DMC´s as well as colleagues from Genmab’s three sites.
As an Associate Director/Director of Drug Safety you will be part of a highly skilled and international team of 9. The position reports to the Head of Global Drug Safety.Key Accountabilities
- 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 primary 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)
- 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
- Perform 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 order to be prepared for audits and inspections
- Participate in audit and inspection activities as required
- Relevant Life Science background and a minimum of 3-5 years practical experience within drug safety and/or pharmacovigilance.
- Experience within the field of oncology is preferred and/or first human trials
- Documented experience from overseeing multiple trials with safety inputs at the level
- International experience from a similar role with internal and external stakeholders
- Vendor Management
- Excellent communication skills in English both written and spoken
Moreover, you meet the following personal requirements:
- Strong communicator 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
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. 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 culture, all aiming to make a difference for cancer patients.
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. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
If you would like additional information about this position before applying using the link, please contact Recruiter Jannie Jensen (email@example.com).
Genmab has selected Korn Ferry as a global recruitment partner to help us manage your application. When uploading your application, it will be transferred to Korn Ferry for their processing. By clicking ‘apply now’ you will see how Korn Ferry manages your application and privacy.
To learn more about Genmab, you can visit our website: www.genmab.com