Aakash Shandilya

-POC, Meetings (MoM's) and Client handling -Medical Literature -Signal Detection/Management -Aggregate Safety Reports -Clinical Adjudication

- Tracking of non-enterable reports which do not qualify for creation in the safety database. - Maintaining a good working knowledge of the AE safety profile of assigned products and labelling documents. - Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting. - Maintaining an awareness of the performance metrics measured by client and striving to remain within established limits.

- Compiled ICSR's (Triage, Book-in, data entry, quality check, narrative writing, medical assessment and reconciliation). - Management of Compliance with the company standard operating procedures and regulatory requirements. - Liaised effectively and maintained excellent relationship with the clients and internal/external contacts. - Responsible for preparation and submission of Root Cause Analysis (RCA) and Corrective Action and Preventive Action (CAPA). -Med DRA coding of events

- Performing preliminary step of Pharmacovigilance, that is, case intake. – Doing research work on adverse events or product complaints, or with an inquiry about the human health product – Receiving calls from consumers and health care professionals with reports – Verbal Probing for necessary information including but not limited to the adverse event(s), the patient’s medical history, – Suspect product, concomitant drugs involved if any, and medication history of patient