Chandaluri Satya NK

• Maintaining and reviewing PADER and Signal schedules and trackers of each client.
• Review of PADERs and Signal reports and related documents as per client-specific SOPs.
• Managing and tracking each PADER/Signal report till the date of submission to regulatory authority.
• Interacting with appropriate client personnel on topics related to the PADER/Signal.
• Archiving digital and physical documents related to PADERs and Signal reports as per client specific SOP.
• Drafting SOPs, and Work instructions about PV process.
• Rising Change control forms for the new SOPs or updated SOPs.
• Monitoring team daily activities and conducting daily and monthly briefings on productivity and quality parameters.
• Participating in client-specific meetings, and internal meetings to represent PADER/Signal.
• Preparation of compliance reports of PADERs and Signal reports monthly.
• Any ad hoc activities as on when required to support the organization.
• Providing training to new employees.

• Drafting PADERs and Signal reports as per the Schedules.
• Maintaining of PADERs/Signal Trackers for timely movement of reports.
• Validating the literature article for ICSR processing and for signal reports, providing proper comments for invalid articles.
• Second-line review of literature validation results.
• Quality review of the spontaneous and literature cases.
• Data entry and reporting of the ICSRs through FDA’s Safety Reporting Portal (SRP).
• Reconciliations activities for literature, and ICSRs.
• Preparation of Monthly compliance report with the elements from all the departments.
• Preparation of trackers as on when required and Presentations to represent team or organization as on when required.

• Communicating with different manufacturing plants for PV-related activities
• Book-in, data entry, and quality review of the complaints in the safety database-ARGUS
• Literature screening, validity assessment, procuring publications, requesting translations
• Performing quality review of citations/publications received from the initial reviewer and confirming the validity for entry into the safety database
• Periodic monitoring of error trends and sharing feedback in team meetings or individual levels if required
• Daily monitoring of the Eudravigilance site for Medical Literature Monitoring (MLM)
• Collation of literature data for a specific molecule weekly and monthly
• Conducting review meetings, preparing presentations and trackers, and reconciliations with partners, and manufacturing units
• Performing literature screening for Signal reports.

• Performing validation, seriousness assessment, causality and listedness assessments for the cases and then booking in to database
• Performing data entry in the database, coding relevant medical terminology by using MedDRA, coding of drugs by using WHO-DD and writing narratives for all ICSRs
• Performing QC for the cases of newly joined associates and providing feedback timely manner to improve their knowledge
• Assigning and tracking of cases for triage and maintaining a cases tracker
• Book-in and processing of legal cases received from Plaintiff/Attorney.