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Associate Director, GDS&PV Signal Detection
3 months ago
At Genmab, we are dedicated to shaping remarkable futures jointly, by producing antibody products and spearheading groundbreaking therapies that revolutionize the lives of patients and the future of cancer treatment and severe illnesses.
When it comes to our team, they embody qualities of empathy, honesty, and impact-focus, while our organization thrives on innovation and is deeply rooted in scientific principles. We strongly believe that embracing our unique identity, striving to excel, and staying true to ourselves are crucial in fulfilling our mission.
Job Title: Associate Director at Genmab
As our Associate Director, your main role is to efficiently implement Signal Management Group surveillance strategies to proactively and systematically detect and evaluate new safety signals and emerging trends from clinical and post-marketing safety data for intricate pharmaceutical products.
Key Responsibilities:
- Identify and assess new safety signals and trends
- Demonstrate knowledge of safety and regulatory guidelines
- Provide medical opinion and safety input
- Responsible for data mining and signal management processes
- Participate in product-specific surveillance plans
- Contribute to submission-related documents
Requirements:
Advanced Healthcare-related Degree with a minimum of 5 years of industry experience in drug safety or related areas. Must have a comprehensive understanding of global health authority regulations and guidelines regarding adverse events reporting and evaluation.
Familiarity with epidemiological principles, safety data analysis methodologies, and public health surveillance tools is preferred. Proficiency in Excel and SAS JMP, as well as the ability to lead analytical projects, is desired.
Location: This role is hybrid, requiring 3 days per week at the Princeton, NJ office.
About Genmab:
Genmab is a global biotechnology company driven by a core mission to enhance patient lives through innovative and unique antibody therapeutics. With a track record of over 20 years, our team's passion, innovation, and collaboration have led to the development of advanced antibody technology platforms and a robust pipeline of therapies.
Genmab envisions transforming the lives of individuals battling cancer and other severe diseases by 2030 through their cutting-edge antibody medicines.
