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 an ambitious growth path and to support this growth Genmab is looking for an additional Global Drug Safety (DS) and Pharmacovigilance (PV) Scientist to join the team in Princeton.

As an Associate Director of Drug Safety and Pharmacovigilance Scientist, you will become part of the Global Drug Safety and Pharmacovigilance department, where you will be responsible for drug related activities in close cooperation with Safety colleagues along with cross-functional team members. This position has a global perspective, and you will interact with stakeholders ranging from regulatory authorities and colleagues from Genmab's four sites. You will be part of a highly skilled and international team. The position reports to the Director, Global Drug Safety & Pharmacovigilance, Scientist Lead.

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
You will also be contributing to the development ofother 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
Contribute to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products
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
Other duties as assigned


Requirements
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 preferred 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

Moreover, you meet the following personal requirements:
Strong communicator and good at building professional relations with 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


Other

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 specialized 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...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity