Qualification- M.B.B.S. in Any Specialization / Medical-MS/MD in Any Specialization
RESPONSIBILITIES
- Triage of adverse event reports in Argus Database
- Medical review of adverse event reports in Argus Database
- Causality assessment of adverse event reports in Argus Database
- Signal management activities
- Medical review of aggregate reports
- SmPC and PIL evaluation, comparison, and updates as required
DESIRED SKILLS
- Expert knowledge of international guidelines and country specific regulatory requirements (FDA, ICH GCP, GVP Modules; respective EU Clinical Trial Directive etc.)
- Experience with ICSR review and assessment
- Solid interpersonal skills and the ability to be flexible in varying environments
- Good attention to detail and decision-making skills.