Beschreibung
Brief Description:Responsible for supporting all operational functions within the Safety Department including, but not limited to, client interface and deliverables, Individual Case Safety Report (ICSR) case processing, project start-up, database configuration, literature review, training and contributing to the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines.
Specific Job Duties:
- Writing of procedural documents such as Adverse Event Reporting Plans (AERPs)
- Adverse Event case processing: receipt, data entry, coding, and evaluation of Adverse Event reports according to the applicable SOPs, including writing the narrative; perform seriousness, listedness and causality assessment
- Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings
- Assist in the reconciliation of clinical and safety databases
- Monitor compliance and ensure appropriate documentation (metrics, deviations)
- Assist in evaluation and validation of systems to support safety e.g. supporting the development teams in safety database configuration and EDC specifications
- Performing global and local literature review
- Project oversight and identification of issues. Escalation.
Requirements:
- Registered Nurse, Pharmacist, or other Life - Science degree
- Comprehensive knowledge of EU, ICH and FDA Regulations and Guidelines both clinical and post marketing
- Experience in pre and post marketing Pharmacovigilance
- Experience in literature review
- Experience in case processing and PV regulatory reporting activities
- Experience in data entry in ICH E2B compliant database
- Knowledge of database management a plus
- Fluent in English, additional language fluency a plus, but not required
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