INTRODUCTION
Your role as a Quality Reviewer is to review the case quality in terms of structured entry of serious and non-serious adverse events onto the global pharmacovigilance safety database.
Your role will also include supporting the end-to-end processing of client requests across all areas and subsidiaries across the globe.
FUNCTION
- Verify that the Case Processor has entered incremental information from initial and follow-up reports into the global pharmacovigilance database
- Analyze the relevance of information extracted from routine source documents
- Evaluate event extraction accuracy
- Check the narratives against routine source documents
- Review all adverse event reports and assess their seriousness and causality
- A review of MedDRA and WHO-DD coding accuracy for reported adverse events, concomitant drugs (suspect, concomitant, historic; international nonproprietary name), and concurrent diseases in accordance with global coding guidelines
- Correct the case and route it to the next level
- Provide training and improvement initiatives based on observed QC issues
- Provide associates with timely feedback
REQUIREMENTS
- Degree in Life Science
- A minimum of 2 years’ pharmacovigilance experience is required
- Business 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