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SAFETY EVALUATION AND RISK MANAGEMENT SCIENTIST (LV)

Hungary - Budapest

Tech People is a European provider of technical skills permanent recruitment and temporary contracting services for multiple industries.

Currently we are looking for

SAFETY EVALUATION AND RISK MANAGEMENT SCIENTIST (LV)


Location: Budapest, XI., hybrid (2 days in office)

Salary: competitive

Type of employment: employee


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

Requirments:

  • 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)
  • Excellent communication skills in English.
  • Candidate needs to be currently eligible to work in Hungary

To apply for this opportunity, please register your CV.

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