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Senior Safety Data Management Specialist
2 months ago
We are seeking an experienced Senior Safety Data Management Specialist to join our Global Drug Safety and Pharmacovigilance (GDS&PV) unit.
Key Responsibilities:- Configure and maintain safety systems, including Argus, to ensure accuracy and timeliness of data.
- Collaborate with internal and external stakeholders to understand requirements and recommend scalable solutions.
- Serve as a liaison 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.
- 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.
We are Genmab, 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. We are committed to building extraordinary futures together, by developing innovative therapies that change the lives of patients and the future of cancer treatment and serious diseases.
Estimated Salary: €85,000 - €110,000 per annum