Drug Safety Specialist

Pharma and Clinical Research


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 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


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


  • 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.


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

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