Safety Evaluation and Risk Management Scientist / BPS
Employer · Tata Consultancy Services
PharmacistOther health professional
BiologistFlexibleFull-timeBudapest
At TCS Hungary, opportunity meets stability in a vibrant and dynamic work environment. Tata Consultancy Services is looking for a Safety Evaluation and Risk Management Scientist to perform signal detection, evaluation, and risk assessment for assigned products using safety databases, scientific literature, and other relevant sources.
Tasks
- 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
Conditions & benefits
Market-leading private healthcare packageAttractive cafeteria package based on your choiceHybrid working opportunityOffice gym and in-house sports clubsOpportunities to grow through diverse roles and career pathsSpecial discounts offered by our partnersAccess to world-class learning platforms such as Udemy and O'ReillyExtensive in-house self-development opportunities
Requirements
- 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