Tata Consultancy Services (TCS) is an IT services, consulting, and business solutions provider partnering with the world’s largest businesses in their transformation journeys.
As a Drug Safety Specialist, you will:
- Provide effective service on behalf of TCS to our client pharma company
- Help our clients comply with pharmacovigilance regulatory responsibility of Individual Case Safety reporting
- Participate and Support in transition for new activities, new scope, or new products to TCS team
- Complete support and assigned training during project transition for ICSR related activities as per process requirement
- QC of ICSR related activities to ensure compliance to Customer and regulatory agency requirements
- Case Intake activity for ICSRs related performance during the work
- ICSR submission activities to Europe and different geographies
- Unresolved issues should be escalated appropriately as per the agreed escalation process
- Should ensures that the Quality and TAT targets defined are met
- Step by step SOPs for the assigned area of activities
- All activities should be in the required timeframes to ensure regulatory compliance
- Experience in Drug Safety or Pharmacovigilance
- Diploma in BPharm/ MPharm/ Alternate Medicine graduate, postgraduate/ BDS
- Knowledge and experience with ICSR submission related regulatory requirements
- Good knowledge of Office 365 tools (Outlook, MS Teams, Word, Excel, and PowerPoint)
- 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.
Email address: email@example.com