Ankush Kumar Email & Phone Number

Assists in processing ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans. Processing All types of reports o Triages ICSRs, and evaluates ICSR data for completeness, accuracy, and regulatory report ability.o Enters data into the safety database. o Codes events, medical history, concomitant medications, and tests. o Compiles complete narrative summaries. o Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. o Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.