Safety Evaluation and Risk Management Physician

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:

Safety Governance and Risk Management

• Conduct and support pharmacovigilance and risk management planning.
• Contribute to benefit-risk assessments and regional Risk Management Plans.
• Provide medical/physician safety input into clinical development activities and key documents, including protocols, Investigator Brochures and informed consent forms.
• Support Safety Review Teams and the implementation of appropriate risk-reduction strategies.

Signal Detection, Evaluation and Labelling

• Perform routine signal detection and provide medical input into signal evaluation for assigned products.
• Evaluate safety and clinical data and discuss findings with key stakeholders.
• Provide recommendations and supporting documentation for labelling updates.
• Assess safety issues related to product defects, manufacturing issues and medication errors.

Regulatory Reports and Submissions

• Author and coordinate periodic regulatory reports, including PSURs and Annual Reports.
• Provide medical review and sign-off for periodic reports and renewal documentation.
• Support license renewals and contribute medical safety input to global regulatory submissions.

Other SERM Activities

• Review and contribute to Safety Data Exchange Agreements (SDEAs) and escalate identified deficiencies.
• Participate in project-related activities, audits and regulatory inspection readiness.
• Contribute to process improvement initiatives and development of safety methodologies.
• Escalate important safety concerns to senior management when required.
• Mentor and train junior scientists and provide medical safety support to Case Management activities.
• Review and approve safety reports to investigators together with the Clinical Development physician.

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:

• Medical degree
• Minimum 5 years of clinical experience
• Minimum 2 years of Pharmacovigilance experience within a Pharmaceutical Company or Contract Research Organization (CRO), including safety surveillance or signal detection activities
• Experience across diverse therapeutic areas is preferred
• Strong level of medical and clinical competence
• Good knowledge of drug safety, clinical development, and ICH/GCP principles
• Excellent written and verbal communication skills, with the ability to present and critically discuss clinical data in both internal and external discussions
• Strong ability to evaluate, interpret, and synthesize scientific and clinical data, demonstrating 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.

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