(Senior) Manager, Global Drug Safety & Pharmacovigilance, Safety Data Management & Analytics

<p><span>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.</span></p><p></p><p><b>About Us</b></p><p>Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.</p><p></p><p><b>The Role</b></p><p>As a (Senior) Manager, Safety Data Management, you will become part of the Global Drug Safety and Pharmacovigilance (GDS&amp;PV) unit, where you will be responsible for safety data management activities including but not limited to configurations and maintenance of safety systems, generation of complex ad-hoc reports, and implementation and validation of safety systems and solutions. This role is hybrid and working from our HQ in Copenhagen, Denmark is expected of you 60% of the time.</p><p></p><p><b>Key Responsibilities</b></p><ul><li>Perform and ensure accurate, timely, and most scalable configurations of safety systems (Argus) including but not limited to (including review of existing <span>configurations)  </span><br/><span>             </span> Studies<br/><span>             </span> Reporting Rules<br/><span>             </span> Code lists</li><li>Work closely with internal and external business users in both GDS&amp;PV and other functions to understand requirements and recommend scalable and best-in-class solutions.</li><li>Serve as a link between GDS&amp;PV, IT, and other functions in technical issues.</li><li>Author or review User Requirements Specification (URS) and User Acceptance Test (UAT) scripts during safety system implementation and upgrade. Review other validation documents.</li><li>Experience with writing  as a link between GDS&amp;PV, IT, and other functions in technical issues.</li><li>Good knowledge on E2B Gateway reporting set-up with regulatory authorities and partners.</li><li>Generate complex reports from the safety database with SQLs.</li><li>Collaborate with Clinical Data Management, the Data Management service provider, and the Pharmacovigilance service provider, in optimizing retrieval of safety data from Electronic Data Capture (EDC)</li><li>Debug complex problems with safety systems and applications using a variety of analytical skills, techniques, and resources, in partnership with IT and/or system vendor(s) where applicable.</li><li>Support during audits and inspections.</li><li>Prepare and maintain GDS&amp;PV departmental Standard Operating Procedures and Working Instructions that address safety database, systems, and data integrity.</li><li>Perform other safety system related activities, as needed or as requested by supervisor.</li><li>Knowledge of clinical systems preferred.</li><li>Should be a good team player and efficiently work with other team members within PV.</li></ul><p></p><p><b>Skills needed</b></p><ul><li>6+ years of experience in the biotechnology or pharmaceutical industry with a focus on Drug <span>Safety/Pharmacovigilance;</span> 3+ years in safety database management.</li><li>Argus or other PV database experience is a must.</li><li>Good knowledge on clinical and post-marketing (PV) domains.</li><li>Should have good collaborating skills with the team members.</li><li>Ability to work in a fast paced environment.</li><li>Strong hands-on SQL skills.</li><li>Good knowledge on PV related health authority regulations.</li><li>A good team member to support everyone in PV team.</li><li>Prior experience with writing/reviewing UAT/URS/Functional Specification (preferred)</li><li>Working closely with IT to get systems/applications related activities.</li><li>Knowledge on analytical tools (like Business Objects, Spotfire etc.) preferred.</li><li>Experience and interest within Artificial Intelligence (AI), NLP, Machine Learning skills are preferred.</li></ul><p></p><p></p><p><b>Other</b></p><p>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.</p><p></p><p>Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment