Director of Global Safety and Pharmacovigilance
6 days ago
We are seeking a highly skilled and experienced Associate Director to join our Global Drug Safety and Pharmacovigilance team at Genmab. As a key member of our team, you will be responsible for ensuring the safe and effective development and marketing of our products.
Key Responsibilities- Perform ongoing surveillance of clinical trials and post-marketing safety data to identify potential safety signals and risks.
- Provide safety review and input to various documents, including regulatory submissions and product labels.
- Contribute to the planning and conduct of Safety Committee activities and Data Monitoring Committee (DMC) meetings.
- Conduct safety training of Genmab employees, CROs, Investigators, and other relevant site personnel.
- Interact with safety and clinical CROs, perform sponsor oversight activities for safety-related tasks, and ensure regulatory compliance.
- Support review of Safety Data Exchange Agreements with 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 preparation for audits and inspections.
- Master's degree in a relevant field (e.g., RN, BSN, MSN, NP, PA, PharmD) and 5+ years of pharmaceutical industry experience in drug safety and pharmacovigilance.
- Experience within the field of oncology is preferred.
- Skilled in signal detection process and managing safety information from clinical development and post-marketing sources.
- Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management.
- Knowledge of drug development process, pharmacovigilance databases, and MedDRA coding.
- Experience with use of safety databases, preferably Argus Safety Database.
- Documented experience from overseeing multiple trials with safety inputs at the Global level.
- International experience from a similar role with internal and external stakeholders.
- Excellent communication skills in English, both written and spoken.
- Strong communicator and good at building professional relations with collaborators and business partners.
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. We are committed to fostering workplace diversity at all levels of the company and believe it is essential for our continued success.
We are an equal opportunities employer and welcome applications from all qualified candidates. If you are a fierce believer in our rooted-in-science approach to problem-solving and are passionate about making a difference in the lives of patients, we encourage you to apply for this exciting opportunity.
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Plainsboro, New Jersey, United States Genmab Full timeJob SummaryGenmab is seeking a highly skilled and experienced Director, Global Safety and Pharmacovigilance to join our team. As a key member of our safety and pharmacovigilance department, you will be responsible for leading the development and implementation of safety strategies for our products, ensuring compliance with regulatory requirements, and...
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