INTRODUCTION

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

FUNCTION

• To identify cases, triage all mail received in the MailboxPerform 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

REQUIREMENTS

• Experience in pharmacovigilance of 3 to 5years
• Pharmacy degree or equivalent
• A strong command of English

OFFER

• TCS has been delivering services from Hungary since 2001, making us a perfect choice if you’re looking for stability.
• We provide a wide range of benefits, including a market leading comprehensive private health care package.
• We offer extensive self-development opportunities: our colleagues have a multitude of training possibilities for personal and professional growth.
• At TCS Hungary there are both vertical and horizontal career options for those who like to challenge themselves and try out different areas and positions.
• You will be part of a global and diverse working environment with relaxation areas, terraces, and a friendly atmosphere.
• You can seize the day with us at our company events, hobby clubs, and sporting initiatives.
• An attractive compensation package.

CONTACT INFO

Arundhati Panigrahi
Email address: arundhati.p@tcs.com