Beschreibung
Signal detection activities* Reviewing reports and data in dedicated tools for signal detection purposes
* Reviewing and assessing clinical and safety database outputs; medically/scientifically analyzing and interpreting aggregate safety data from clinical trials and post-marketing sources
* Reviewing the scientific literature for safety surveillance and signal detection purposes
* Analyzing safety signals
* Developing and maintaining MedDRA CMQs for the analysis of potential signals and aggregate safety data
* Contributing to the development of Emerging Safety Issue
* Reports and respective communication to external stakeholders
d(RMP) and periodic report
* Delivering content related input into (d)RMPs
* Delivering content related input into periodic safety reports
* Providing responses to HA questions related to RMPs or periodic safety reports
Clinical trial activities
* Providing safety related input into the development of other clinical trial related documents
* Providing safety related input for data monitoring committees
* Providing responses to HA questions related to clinical trials
in-licensing
* Provide support to in-licensing activities (Database transfer)
* Strong MedDRA skills
* Good CMQ und d(RMP) skills
* Good knowledge in PhI to Ph III studies safety
* Be able to support a program with ongoing PhI to Ph III studies safety
* Be able to deputize the Safety Strategy lead as required
* Be able to present as safety committees or boards
* Strong documentation standards skills
* English skills: business fluent
Kontaktperson: Personalreferentin Mrs. Julia-Elisabeth Kratz
FERCHAU GmbH
Niederlassung Darmstadt
Rösslerstr. 88
64293 Darmstadt