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