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Associate Director, Global Drug Safety - Utrecht, Nederland - Genmab
Beschrijving
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.
Genmab is on the lookout for dynamic professionals to oversee the safety aspects of its pharmaceutical products and clinical trials.
Engage in continuous surveillance activities, including signal detection and evaluation of safety data from Genmab's clinical trials in collaboration with the safety physician.
Regulatory Compliance:
Manage Safety Data Exchange Agreements with partners as needed. A minimum of 6 years of pertinent experience in Clinical or Drug Safety and Pharmacovigilance. Demonstrable expertise in medical safety operations, including signal detection, risk management, and periodic reporting. Proficient understanding of and experience with FDA/EMA/PMDA/ICH requirements, good clinical practices, and the nuances of pharmaceutical clinical development.
Project Management & Skills:
Proven capability in planning, orchestrating, and managing multiple projects simultaneously.
Essential skills include data analysis, critical thinking, problem-solving, teamwork, and exceptional communication and presentation abilities in English (both oral and written).
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
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.
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics.
For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.Genmab 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 websitePlease note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
