We're partnered with an exciting commercial-stage biotech company who, due to their growth, are building their Safety operations in Munich.
- Implementation of routine system configuration including product, study, and license.
- Assist with creating reports using Oracle Business Intelligence reporting tool.
- Experienced in generating outputs from the Global Safety System (e.g., PSUR, DSUR and PBRER);
- Assist in the development of system support related process, SOPs, Work Instructions and manuals and Support Inspection and Audits.
- Extensive experience in Pharmacovigilance Safety at global scale with strong knowledge on Pharmacovigilance and drug safety regulations (ICH, GxP, GVP modules with new Pharmacovigilance legislations, 21CFR Part 11 and GAMP 5 Standards etc.).
- Sound knowledge and strong experience in defining PV processes, implementing/managing IT systems (ARISg and Argus), safety databases - Oracle DB, EDMS and QMS.
- Profound knowledge of Safety Database set up and handling, including ARGUS.
- Industry experience in drug safety, including clinical development safety and post-marketing Pharmacovigilance in a global environment
- Typically the level of this role would require at least 10 years of such experience
- Working knowledge of safety database systems, local case reporting, queries.
- Bachelor's Degree in scientific discipline or Informatics or similar area.
- Work experience in CRO/biotech/pharmaceutical industry.
- Experience in Study configurations in Safety Systems.
- Experience with Safety Database, especially Argus.
Role is to be based in Munich and office-based.