Come to one of the biggest IT Services companies in the world! Here you can transform your career!Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing to our success in a collaborative environment. We are looking for a Case Processor. In this role you will: Triage all the mails received in Mailbox to identify cases Perform Case Intake activity for ICSRs Book-in case/s from email;
ensure that source email is saved in database (in appropriate format) as ICSR source document Process case as per the detailed case processing guidance document ensuring compliance to process and requlatory requirements Perform ICSR submission activities to different geographies Perform submission activities within agreed timelines with high quality with adherence to regulatory guidelines and applicable standards, and processes. Perform QC of ICSR related activities to ensure compliance to Customer and regulatory agency requirements Maintain open and timely communication;
participate on special projects and process improvement initiatives Knowledge and experience with ICSR submission related regulatory requirements Regular interaction with internal stakeholders and external stakeholders Escalates unresolved issues appropriately as per the agreed escalation process Ensures that the Quality and TAT targets defined are met Understand the transition plan for any new scope with perspective of training related activities Participate in transition for new activities, new scope or new products Support in transition of new scope to TCS team Provide complete support during project transition for ICSR related activities Complete assigned training as per process requirement. Mandatory Skills: Fluent English Advanced Spanish Any lifescience degree – Biology, Pharmacy, Dentist, etc. Knowledge/previous experience in pharmacovigilance, ICH/GCP, Clinical Data, Drug Safety and Regulatory process
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ensure that source email is saved in database (in appropriate format) as ICSR source document Process case as per the detailed case processing guidance document ensuring compliance to process and requlatory requirements Perform ICSR submission activities to different geographies Perform submission activities within agreed timelines with high quality with adherence to regulatory guidelines and applicable standards, and processes. Perform QC of ICSR related activities to ensure compliance to Customer and regulatory agency requirements Maintain open and timely communication;
participate on special projects and process improvement initiatives Knowledge and experience with ICSR submission related regulatory requirements Regular interaction with internal stakeholders and external stakeholders Escalates unresolved issues appropriately as per the agreed escalation process Ensures that the Quality and TAT targets defined are met Understand the transition plan for any new scope with perspective of training related activities Participate in transition for new activities, new scope or new products Support in transition of new scope to TCS team Provide complete support during project transition for ICSR related activities Complete assigned training as per process requirement. Mandatory Skills: Fluent English Advanced Spanish Any lifescience degree – Biology, Pharmacy, Dentist, etc. Knowledge/previous experience in pharmacovigilance, ICH/GCP, Clinical Data, Drug Safety and Regulatory process
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