Associate Director, Global Drug Safety
1 week ago
We are seeking a highly skilled and experienced Associate Director, Global Drug Safety to join our team. As a key member of our Global Drug Safety and Pharmacovigilance department, you will be responsible for ensuring the safety of our products throughout the clinical trial and post-marketing environments.
Key Responsibilities- Perform safety review of Adverse Event reports for Genmab products
- Perform ongoing surveillance (including signal detection/evaluation) of Genmab clinical trials and post marketing safety data
- 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
- Contribute to the development of other documentation such as: Investigator's Brochures, and Subject Informed Consent
- Contribute to HA requests and review key submission documents
- Contribute to safety-related documents for Genmab products throughout product lifecycle from FIH to post-marketing, including monthly safety surveillance, Safety Assessment Reports for potential signals/risks, RSI in IB, ADR in the CCDS and product labels, Aggregate Safety Reports (e.g. DSUR, PBRER, PSUR, PAER), RMP, and responses to ad-hoc requests for safety information internally and externally
- Contribute to the planning and conduct of Safety Committee activities and DMC's
- 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
- Support review of 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 preparation of audits and inspections
- Participate in audit and inspection activities as required
- Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PA, PharmD) and 5+ years of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments
- Experience within the field of oncology is and/or first human trials
- Experience authoring safety signal assessment report, DSUR, PBRER, RMP, and RSI
- 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
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- antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next- 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.
By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
We are committed to fostering workplace 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,,, (including,, and ),,,, or genetic information.
Learn more about our commitments on our website.
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 website .
Please 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.
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