At Fortrea youll play a vital role in safeguarding patients by ensuring the quality and accuracy of clinical safety data. As an Assistant II PSS you will contribute to the review and processing of adverse event reports from clinical trials and marketed products helping advance medical innovation while maintaining the highest standards of compliance and patient safety.

This role is based in our Sofia office with the flexibility to work remotely on occasion.

Key Responsibilities

As an Assistant II PSS at Fortrea you will:

• Support the collection processing and reporting of adverse events (AEs) and serious adverse events (SAEs).

• Enter safety data into tracking systems and ensure accuracy and completeness.

• Draft patient narratives and code adverse events using MedDRA.

• Assist with safety database reconciliation and quality checks.

• Prepare and submit safety reports to clients regulatory authorities ethics committees and investigators within agreed timelines.

• Maintain project documentation safety files and study archives.

• Collaborate with colleagues across safety regulatory and clinical functions to ensure compliance with global requirements.

• Support training and mentorship of junior staff as needed.

Required Qualifications

• Degree in Life Sciences (Biology Pharmacy Nursing Medical Sciences or related field) or equivalent experience.

• 1-2 years of experience in safety case processing pharmacovigilance or related clinical research areas.

• Familiarity with safety databases AE/SAE reporting and regulatory submissions is a plus.

• Strong attention to detail with the ability to manage multiple tasks.

• Proficiency with MS Office and ability to learn new systems quickly.

• Fluency in English (written and spoken); local language proficiency may be required depending on location.

What We Offer

• The opportunity to contribute to improving patient safety in a global healthcare environment.

• A supportive collaborative workplace culture with opportunities for growth.

• Access to training mentoring and career development programs.

• A diverse and inclusive workplace that values different perspectives and backgrounds.

Join us at Fortrea and help shape the future of clinical research and patient safety. If youre ready to grow your career while making a meaningful impact we encourage you to apply today.

Learn more about our EEO & Accommodations request here.