Job Description 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 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
- 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 that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
For US based candidates, the proposed salary band for this position is as follows:
$142,500.00 $237,500.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.
About You- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
- 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
- You are not afraid to grapple with the unknown and be innovative
- You have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so
Locations Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. 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.
About Genmab 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. 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.
Our commitment to diversity, equity, and inclusion We are committed to fostering workplace diversity 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 race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, 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 . click apply for full job details
