PV & Safety Expert

Possesses extensive experience in pharmacovigilance, having worked with major pharmaceutical companies focusing on safety report processing and system development

Demonstrates strong skills in developing and implementing pharmacovigilance processes and tools, including reconciliation processes, eForms, and automated software solutions, enhancing efficiency and compliance

Holds a PhD in Molecular Psychiatry and a Diploma in Biology, providing a solid scientific foundation for roles in drug safety and pharmacovigilance, with a focus on quality management and compliance

Practical knowledge of global PV regulations (including GVP modules, ICH guidelines, and FDA/EMA expectations) and has supported audits and inspections in various roles

Already placed via K-Recruiting with the best references

Development and implementation of the reconciliation process with partners worldwide

Timely processing of various backlogs

Support for case managers and safety specialists through the development of processes and tools, such as eForms and automation through software solutions

Support during peak workloads in daily business and backlogs

Significant contribution to 'Best Practices'

Development of the follow-up process

Development of the pharmacovigilance system

Capture, process, document, and follow up on safety-relevant reports

Significant contribution to the development of processes and process descriptions

Support for the PV department after the spin-off (developing processes and process descriptions, capturing, processing, and documenting safety-relevant reports)

Implementation of a software solution for calculating deadlines for tracking safety-relevant reports

Implementation of standard letters for tracking safetyrelevant reports

Development of the pharmacovigilance system

Capture, process, document, and follow up on safetyrelevant reports

Improving collaboration with the local Quality and Complaint Hub, establishing an eForm

Developing and implementing a pharmacovigilance agreement with the German Rheumatism Research Center (DRFZ)

Capture, process, document, and follow up on safetyrelevant reports

Responsible for collaboration with local QA and the Complaint Hub

Reconciliation of safety-relevant reports with local Quality and DRFZ

Implementation of corrective action plans

Study support, pharmacovigilance agreement

Reviewing new signals

Developing and implementing Red Hand Letters

Local PSUR acknowledgements

Regions Specialist

Development of a tool for creating Appendix C1 and A3 of the PSMF

Design and creation of the departmental newsletter

Developing processes and process descriptions for the pharmacovigilance system

Operational support for Global Clinical Safety Pharmacovigilance Regions Leads and the Safety Officer Networks in the affiliates

Development and updating of procedural workflows

Concept and design of process documentation

Development of the archiving system for process documentation

Development of the system for forwarding safety reports (SUSAR, SUSAR Line-Listing, DSUR) from the study database to ethics committees and investigators