Drug safety expert with special skills in
Safety report submission to the regulatory bodies MHRA/EMA/FDA
Case processing & assessment
Safety (ARISg, Argus, Clintrace) and Clinical (Oracle, Medidata EDC) database knowledge
ICSR processing review, monitoring, and assessment
SAE reconciliation and tracking
Working knowledge of ICH/GCP Guidelines and US CFR 314.80, 312.32; MedDRA and WHODrug Globa
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Our content and services may vary by location.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Pharmacology, Bachelor of Science
- Language Skills
- English (native), German (business fluent)
- Relevant Expertise
- Case Processing Expert, Case Assessment, Safety Data Management, MHRA, EMA, FDA, Pharma, Biotech
Key-Facts
Extract from previous activities
Biotechnological Company, Germany (via K-Recruiting)
Case Processing Specialist
Case processing activities including E2B reporting of cases to EMA and ADIS literature
ICSR processing review, monitoring, and assessment
Importing of health authority cases (EMA and MHRA) from inhouse-proprietary database into ARISg safety database
Collaboration with national safety officers globally on triage safety assessment, discrepancy management of cases
Reporting of AE / special case scenarios
Documentation / tracking / record keeping of the assigned compounds
Case processing safety activities
Responded to inquiries from our vendors or health care professionals on safety issues
Training
Ownership of case processing of the company’s clinical trial studies
Collaboration with a CRO in case management
Pharmaceutical Company, Switzerland
Drug Safety Manager
Sort, collect and assemble safety relevant information received in global drug safety
Log and track safety relevant information from initial receipt up to submission to regulatory authorities
Responsible for booking cases in Argus Safety database, search for duplicate and triage cases according to set priorities
Send acknowledgements of receipt to reporters/investigator
Track follow-up information with data clarification forms (DCFs)
SUSAR submission to investigators and IRBs/ECs, review
submission requirements and ensure timely compliance with regulatory timeframes
Support compliance activities through participation in inspection readiness activities as required
Pharmaceutical Company, Germany
Case Processing Consultant
Responsible for Case assessment, reconciliation, and quality checks with other departments (e.g., Medical Information, QA, and third-party contractors) for potential AEs resulting from medical inquiries, quality related complaints and other sources
Literature peer review, coordination and update of monthly operational report, support with DSUR preparation, invoices, accruals, update, and upload of pharmacovigilance master file annexes into the in-house validated document management system
Training of new starters