Kasturi Banerjee

About Kasturi Banerjee

Completed M. Pharm- Pharmaceutics. Dealing with patient safety on a regular basis. Have a valid pharmacist license. Have had appropriate industrial training in production and pharmacovigilance.

Experience

1. Safety Science Coordinator-2

   Fortrea

   Jul 2023 — Present · Bengaluru, IN

   Assist in the processing and reporting of expedited safety reports (ESRs) to Clients, Regulatory Authorities, Ethics Committees, Investigators and Covance Project Personnel. • Maintenance of Adverse Event tracking systems like Argus and iMedidata RAVE. Set-up and maintenance of project files, core process files and central safety files using CTMS. • Intake and triage of incoming Serious Adverse Event reports by reviewing the completeness of the reports and making sure that the reports are anonymized accurately to protect confidentiality. • Ensure all incoming reports are appropriately stamped, logged into the departmental tracking application and forwarded in timely manner to the next workflow. • Assist in maintenance of files regarding adverse event reporting requirements in all countries. Ensure submission of client related documents is sent to the client within designated timeframes. Assist global teams during audits. • Work within the Standard Operating Procedure system, including departmental Work Instructions. Regularly support in audit activities and raise CAPA when required using QMS systems. • Provide administrative support to Patient Safety Solutions and Adjudication (PSSA) personnel. Assist the Drug Safety Associate/Senior Drug Safety Associate in preparation of materials needed for client and/or investigator meetings. • Maintain and distribute a weekly schedule for PSSA staff. • Mentor new team members.

Education

• Carmel Junior College

  Economics Science (Class 10- ICSE) Bio Science (Class 12- ICSE)

  2002 — 2014

• KLE University

  M. Pharm, Pharmaceutics and Drug Design, 8.63/10

  2018 — 2020

• De Nobili School

  Kindergarten

  1999 — 2001

• Siksha 'O'​ Anusandhan University

  B. Pharm, Pharmaceuticals, 9.53/10

  2014 — 2018