Chanikya Regeti

• Authoring and review of Aggregate reports PSUR PADER DSUR and ACO
• Collecting organising analysing presenting the available data as per project procedure.
• Organizing kick off meetings with stakeholders.
• Client relationship management
• Drafting and Quality review of signal management reports using available data
• Ensure compliance to client SOPs conventions and guidelines for all activities performed
• Supports Audit and regulatory inspections
• Literature monitoring for Aggregate reports

. Drafting of Signal Management reports such as Validation and Detection

. Generation of line listings and summary tabulation from Argus Safety Database for Signal Management

. Referring ADRs Monitor tracker, PRAC meeting assessments. WHO newsletters for ongoing signal tracking

. Medical assessments for drug event pair for signal

. Literature search for the molecules for signal management using search strings

. Ensure compliance to SOPs and regulatory guidelines