Ramya Prabhakar

Pharmacovilance Operations Manager @Amgen

London, GB

Daily resolution of queries relating to Device Safety processes.· Liaison between vendors and Quality teams. · Provide daily monitoring of various activities relating to processes within BioConnect.· Provide support for IS related issues derived from BioConnect processes.· Support resolution of case related specific queries for all Amgen PM products.· Support ICSR processing to ensure high quality cases in a timely manner to meet all worldwide regulatory authority requirements.· Support vendor oversight of all case processing activities. Perform daily device case review for quality control.· Escalation/review of case level issues.· Ensure that individual ICSRs are evaluated for reporting in compliance with regulations and contracts.· Reporting of ICSRs within time frames determined by regulations and contracts.· Support reconciliation as required by the safety agreement.· Support the development and delivery of convention-related training material.· Review and respond to AE (Adverse Events) intake, triage, and submission queries.· Provide vendors with resources and training to perform their role.· Audit & external inspection support.· Perform other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by supervisor.· Support interactions with business partners (license partners) distributors and CROs for all case processing activities. Support management of multiple business partner relationships for case management.

ST Teresa's Convent

High School

Manipal Academy of Higher Education

Master’s Degree

Mount Carmel College, Palace Rd, Bengaluru

Bachelor’s Degree