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

Key Skills

Aartificial intelligence, Data Analytics, Data management, Database, IT, Machine learning techniques, Natural Language Processing (NLP), SQL, Writing

Job Description

The Role & Department

As a Manager, Safety Data Management, you will become part of the Global Drug Safety and Pharmacovigilance (GDS&PV) department, 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.

Key responsibilities include

Perform accurate and timely configurations of safety systems (Argus) including but not limited to:

• Product

• Studies

• Reporting Rules

• Code lists

• Generate line listings and tabulations from the safety system, using the reporting tool and/or SQL

• Support to or author system related SOPs/Working Instructions.

• Support during audits and inspections

• Perform other safety system related activities, as needed or as requested by supervisor

• Should be a good team player and efficiently work with other team members with PV

Requirements

• 5+ years of experience in the biotechnology or pharmaceutical industry with a focus on Drug Safety/Pharmacovigilance; 3+ years in safety database management

• Argus or other PV database experience is a must

• Good knowledge on clinical and post-marketing (PV) domains

• Should have good collaborative skills with the team members

• Ability to work in a fast paced environment

• Experience in writing SQL

• Good knowledge on PV related health authority regulations

• A good team member to support everyone in PV team

• Prior experience with writing/reviewing UAT/URS/Functional Specification (preferred)

• Working closely with IT to get systems/applications related activities

• Knowledge on analytical tools (like Business Objects, Spotfire etc.,) preferred

• Experience with Artificial Intelligence (AI), NLP, Machine Learning skills are preferred

The role is located in Copenhagen, DK or Utrecht, The Netherlands, or Princeton NJ, US and is a hybrid role.

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 https://www.genmab.com/privacy.

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.