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.
Contract position - 6 months - Hybrid
Role
A member of the Global Drug Safety & Pharmacovigilance team, focused on safety operations including but not limited to the collection and processing of safety information from various sources, quality control of safety data entry, regulatory submission of individual cases safety reports (ICSRs), and case exchange with business partner.
Key Responsibilities:
- Perform both real-time and retrospective quality control of safety case data entry to ensure quality and compliance with the data entry conventions and MedDRA/WHO DD coding conventions.
- Support the management of the daily safety case workload as needed ensuring compliance with regulatory submissions and internal timelines including, but not limited to:
- Monitoring the workflow status of safety cases and or the pending regulatory submissions of ICSRs.
- Communicating to safety vendor, safety physicians, and/or submission stakeholders as needed
- Provide guidance on questions concerning Safety Operations based on, not only company conventions, but also ICH and regulatory guidance.
- Ensure the reporting destinations are correctly populated for each safety case and approve a regulatory report for all destinations in the safety database as applicable.
- Monitor and triage email communications received in Safety Operation Mailboxes
- Review and, with oversight, provide input on behalf of Safety Operations on individual study-specific documents including but, but not limited to, Safety Operational Management Plan, SAE Reconciliation Plan, Data Validation Plan, and Safety Reporting Form Specifications Document.
- Support the set-up and maintenance of individual study-specific activities.
- Perform reconciliation with internal/external stakeholders to ensure cases are exchanged as per the relevant agreement.
- Analyze and provide reason(s) for late submission/distribution of safety reports, as applicable.
- Contribute to the creation or updating of Standard Operating Procedures, Working Instructions, and training materials concerning safety case processing and operations.
- Participate or support Genmab initiatives and projects on Safety Operations behalf
- Other activities, as needed or as requested by supervisor.
Skills and Experience
Drug Safety professional with minimum 3 years of experience within drug safety and PV inclusive of case quality control and regulatory submissions of ICSRs worldwide.
- Bachelor s/Master s degree in science.
- Knowledge of ICH E2B(R2) and (R3) specifications and entry guidance.
- Knowledge of pharmacovigilance reporting rules and timelines.
- Ability to interpret health and medical records such as adverse event reporting forms, a discharge summary, etc.
- Experience with clinical and/or post-marketing case processing, including MedDRA and WHO DD coding and narrative writing.
- Experience with safety database; Argus is a plus but not mandatory.
- Experience with EDC for clinical trial data collection is a plus but not mandatory.
- Excellent in detailed-oriented tasks.
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
Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.
When you work with us, you ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.
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
