Regulatory Officer (Safety Reporting)

About the role

PSI CRO, a global company founded in 1995 with more than 3,200 people working on the frontline of medical science, is looking for a Regulatory Officer (Safety Reporting) to join its international team. The role supports the regulatory safety reporting aspects of clinical research projects, streamlines communication, maintains electronic systems and manages documents. It is an office-based position in Belgrade.

Key responsibilities

• Act as the point of contact for clinical project teams, support services and client companies on safety reporting matters
• Coordinate accurate and timely reporting of safety issues to authorities
• Manage documents, including filing, processing and quality control
• Update and maintain tracking systems, knowledge repositories, working files and schedules

Required profile

• College or university degree, or an equivalent combination of education, training and experience
• A Life Sciences degree is a plus
• Prior experience in clinical research, with a focus on the regulatory aspects of safety reporting
• Full working proficiency in English
• Ability to plan, multitask and work in a dynamic team under tight deadlines

Required skills

• Proficiency in MS Office applications
• Communication and collaboration skills