Beschreibung
* Undertake signal detection activities on safety data sets from various sources, such as spontaneous adverse event listings, clinical trial datasets, reports or datasets from observational studies* Present summaries of the data
* Analyze safety signals, author signal evaluation reports and present results to governance committees as required
* Review and summarize publications from the scientific/medical literature and critically appraise the findings
* Contribute individual safety relevant key sections for the preparation of aggregate safety reports per projected timelines
* Contribute to risk management activities including authoring of safety related justification documents in support of company/development core safety information and safety relevant label updates, risk communications, Risk Management Plans
* Assist in responding to Health Authority requests
* Contribute safety relevant content to HA briefing books, integrated summary of safety analyses, CTD modules, Renewals and safety variations
* Conduct analyses for aggregate safety monitoring during study conduct
* Contribute individual safety relevant input for the preparation of submission dossiers, Investigator's brochure and Informed consent form and other trial related documents
* Profound experience in science, medicine/health sciences, or pharmaceutical science
* Progressive experience within the Pharmaceutical/Biotech industry or Health Authority and advanced experience in Pharmacovigilance
* Experience in signal management - specifically signal detection in varying data sources across the product life cycle, as well as problem solving in the methods and approaches to answering complex regulatory queries
* Advanced understanding of pharmacovigilance and global clinical safety methodology and regulations, guidelines and standards
* Understanding of ICH GCP and drug development
* Computer proficiency in basic database entry and graphics presentations (e.g.spotfire)
* Business fluent in English, German language skills desirable
* Remote approx. 90%
* Profiles in English
Schlagwörter:
Signaldetektion, Pharma, Pharmazie, Medizin, Datensicherheitsspezialist, Daten, Sicherheit, Spezialist, Pharmazie, pharmazeutisch, Gulp, Merck, Biotechnik, Gesundheitswesen, Chemie, Wissenschaft
Kontaktperson: Personalreferentin Mrs. Judith Guldan
FERCHAU GmbH
Niederlassung Darmstadt
Rösslerstr. 88
64293 Darmstadt