Tata Consultancy Services



This job involves helping our client, which is a pharmaceutical company, to comply with pharmacovigilance regulatory requirements.

• To identify cases, triage all mail received in the Mailbox
• Perform the Case Intake activity for ICSRs
• Book-in case/s from email
• Save source email as an ICSR source document (in appropriate format) in the database
• Ensure compliance with all process and regulatory requirements by processing the case according to the detailed case processing guidance document
• Submit ICSRs to different geographies
• Maintain high quality regulatory compliance and adhere to regulatory guidelines and applicable standards during submission activities
• Provide training activities in accordance with the requirements
• Perform quality control of ICSR-related activities to ensure compliance with regulatory requirements and customer requirements
• Communicate openly and promptly
• Work on special projects and process improvement initiatives
• Maintain regular contact with internal and external stakeholders
• Escalate unresolved issues according to the escalation process
• Maintain quality and time-to-market targets
• Identify the training activities relating to any new scope of work
• Participate in the transition of new activities, new scopes, or new products

• Pharmacy degree or equivalent
• A strong command of English

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