Safety Evaluation and Risk Management Scientist / BPS

About TCS Hungary:

At TCS Hungary, opportunity meets stability in a vibrant and dynamic work environment. Tata Consultancy Services is one of the world’s fastest-growing technology partners, employing over 600,000 people from 152 nationalities across 55 countries. Since our establishment in 2001 in Budapest, we’ve been committed to delivering exceptional services through the power of digital technology.

What You Will Do:

• Perform signal detection, evaluation, and risk assessment for assigned products using safety databases, scientific literature, and other relevant sources.
• Prepare and review safety reports, including PSUR/PBRER, DSUR, Risk Management Plans (RMPs), and signal evaluations
• Provide clear safety evaluations, scientific conclusions, and recommendations.
• Identify, assess, document, and escalate safety signals and emerging safety issues, supporting appropriate risk-mitigation actions
• Support regulatory submissions and health authority responses, ensuring compliance with Good Pharmacovigilance Practices (GVP), CIOMS recommendations, and other relevant regulatory requirements
• Support and review Safety Data Exchange Agreements (SDEAs), ensuring compliance and data quality
• Evaluate safety issues related to product quality, manufacturing, or medication errors
• Collaborate with cross-functional and global teams and manage multiple safety-related activities and timelines
• Support audit and inspection readiness, safety agreements, and continuous improvement of pharmacovigilance processes

What Do We Offer:

• Market-leading private healthcare package
• Attractive cafeteria package based on your choice
• Hybrid working opportunity
• Office gym and in-house sports clubs
• Opportunities to grow through diverse roles and career paths
• Special discounts offered by our partners
• Access to world-class learning platforms such as Udemy and O'Reilly
• Extensive in-house self-development opportunities

What You Will Bring:

• Degree in Life Sciences / Pharmacy / Biomedical Sciences (Advanced degree preferred)
• Mandatory 3-5 years of experience in Author and review aggregate safety reports & Signal Evaluation
• Fluency in English
• Strong knowledge of ICH guidelines, GVP modules, CIOMS, and regulatory requirements
• Experience in global matrix environments with effective stakeholder communication
• Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions
• Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
• Good knowledge of MS Office)

About Your Contract:

• Full-time position (40 hours per week)
• Permanent employment contract
• Hybrid working model
• You must be eligible to work in Hungary

Join our diverse, collaborative workplace where your growth matters!

About Your Application:

Please include only information in your CV that is directly relevant to the role you are applying for. Our recruitment team will carefully review all applications and contact only those candidates whose profiles best match the current requirements.

Our data protection policy is as follows: https://www.tcs.com/who-we-are/legal/tcs-privacy-notice/tcs-privacy-notice-european-union