Chetan Ingle Email and Phone Number

Working on signal detection, aggregate reports, Medical openion Meno, HHE report, RTQ, and providing support to global safety officer. Also, handling the safety team.

Aggregate report writer (PSUR/PBRER, PADER and other country specific reports).

PSUR Writing.ASPR Filtration.Preparation of case narrative and Company Comment.Coding of adverse event ( MedDRA).Preparation of cumulative and interval summary tabulations of serious and non serious event and Line Listing. Preparation of Background information for Signal detection report

Overall in-charge of day-to-day activities for PV projects. Provide technical expertise to PV team. Provide regular status reports on work completion to Group Lead.Assign cases on a regular basis to the Case Handlers in the team. Attend additional leadership training to improve leadership qualities.Ensure that Case Handlers cases are completed as per agreed timelines.Involved in audit preparation (MHRA) Data entry for expeditable and non-expeditable cases (including MedDRA coding of events, diseases, capturing of Concomitant medications, assessing Rechallenge and Dechallenge).Querying back to marketing company regarding critical issues.Narrative writing.Experience in mass litigation and literature cases handling.