Samuel A.

Process clinical data relating to Adverse Events/Serious Adverse Events. Issue data clarification forms (DCFs) to investigators sites Performs routine PV functions as required. Monitors E2B compliance and validates electronic safety data capture. Performs systematic quality check on data integrity in Oracle Clinical (OC) & Adverse Event Reporting System (AERS) databases. Assist in the preparation of Safety reports Ensure company compliance with regulatory guidelines pertaining to pharmocavigilance Systems Identifying process improvements and escalating opportunities to supervisor. Respond in a timely manner to requests from Sponsor to ensure compliance to regulatory timelines. Maintain consistent and accurate patient data electronically by reconciling data discrepancy. Report adverse events in accordance to PV SOPs. Process lab data received for Risk Management programs, including entry into relevant database and QC. Transcribe sponsor`s queries to DCFs and sent to investigator site in a timely manner. Prepares and monitors Company Core Safety Profiles and enters core event data into safety database (AERS) Assist in the maintenance of unit SOPs, IM & SG Safety. Maintain departmental document management, including filing and scanning of source documents. Performs all other duties, special projects and after-hour coverage of the PV unit as assigned. Escalates to Project leader/Medical Lead, calls and requests for clinical oncology Health Care issues patient risk management. Develop process improvement initiatives in consultation with management. Writes, review and QC clinical study report narratives among others.