Senior Manager, Global Drug Safety and Pharmacovigilance
2 weeks ago
At Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our people are caring, candid, and impact-driven, and our business 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.
About Us
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.
The Role
As a Senior Manager, Safety Data Management, you will become part of the Global Drug Safety and Pharmacovigilance (GDS&PV) unit, where you will be responsible for safety data management activities including 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, requiring you to work from our HQ in Copenhagen, Denmark 60% of the time.
Key Responsibilities
- Perform and ensure accurate, timely, and scalable configurations of safety systems (Argus), including review of existing configurations.
- Work closely with internal and external business users in both GDS&PV and other functions to understand requirements and recommend scalable solutions.
- Serve as a link between GDS&PV, IT, and other functions for technical issues.
- Author or review User Requirements Specification (URS) and User Acceptance Test (UAT) scripts during safety system implementation and upgrade.
- Generate complex reports from the safety database using SQL.
- Collaborate with Clinical Data Management and the Pharmacovigilance service provider to optimize retrieval of safety data from Electronic Data Capture (EDC).
- Debug complex problems with safety systems and applications in partnership with IT and/or system vendors.
- Support during audits and inspections.
- Prepare and maintain GDS&PV departmental Standard Operating Procedures and Working Instructions.
- Perform other safety system-related activities as needed or requested by supervisor.
Skills Needed
- 6+ years of experience in the biotechnology or pharmaceutical industry with a focus on Drug Safety/Pharmacovigilance; 3+ years in safety database management.
- Experience with Argus or other PV databases is a must.
- Good knowledge of clinical and post-marketing (PV) domains.
- Strong collaboration skills with team members.
- Ability to work in a fast-paced environment.
- Strong hands-on SQL skills.
- Good knowledge of PV-related health authority regulations.
- Prior experience with writing/reviewing UAT/URS/Functional Specification preferred.
- Knowledge of analytical tools (like Business Objects, Spotfire) preferred.
- Experience and interest in Artificial Intelligence (AI), NLP, and Machine Learning skills are preferred.
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 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 for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.
Our Commitment to Diversity, Equity, and Inclusion
We are committed to fostering workplace diversity at all levels of the company. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex, national origin, age, disability, or genetic information.
Location: Copenhagen - Carl Jacobsens Vej 30
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