The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). Triage of incoming reports for completeness, legibility and validity.

• Initial data entry of case reports into safety database/tracking system
• Data mining/extrapolation, source data examination and cleaning
• Assessment of case reports for seriousness, causality and expectedness
• Adverse event (AE) and drug coding
• Requesting follow-up i.e. written, telephone
• Perform query resolution and initiate direct contact/follow-up with sites for additional information
• Create and maintain project specific working files, case report files and project central files
• Writing case narratives; medical and technical writing for clinical study reports and annual reports
• Inform Medical Project Managers and Regional Head of PV Operations of potential change-in scope of projects
• Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities
• Assist with additional Drug Safety activities as required