Saloni

Professional Experience:

PHARMACOVIGILANCE Drug Safety Specialist⁺ (April 2017 to August 2019)

Ø  Expertise on Clinical trial cases and Legal case processing.

Ø  Received and tracked information regarding potential adverse events submitted by all reporters in the form of E2B, Jaspers, CIOMS, including, healthcare professionals, plaintiffs, co-palintiffs, co-manufacturers, call centers, consumers and other company representatives accurately with in defined reporting timelines.

Ø  Review, assess, triage, process and reporting the adverse event reports for Investigational and Marketed products according to applicable regulations, guidelines, SOPs and project requirements within the regulatory timelines by meeting the quality standards.

Ø  Ensure a duplicate check is conducted against the Global safety database (SAPPHIRE) in accordance with SOPs for ICSRs (Individual case safety reports) in order to find existing case file and creating an electronic case report file for a new case.