Global Drug Safety Expert
7 days ago
We are seeking a highly skilled Global Drug Safety Expert to join our Global Drug Safety and Pharmacovigilance (GDS&PV) unit.
In this role, you will be responsible for configuring and maintaining safety systems, generating complex reports from the safety database using SQL, and collaborating with Clinical Data Management and the Pharmacovigilance service provider.
About Your Key Accountabilities
- Configure and maintain safety systems, including reviewing existing configurations.
- Work closely with internal and external business users 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.
About Your Background
- 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.
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