Safety Science Specialist

Roles & Responsibilities:
• Manage receipt, processing, and submission of Adverse Event (AE) and Serious Adverse Event (SAE) reports from clinical trials and post-marketing sources
• Enter safety data into AE tracking systems, write patient narratives, and code events using MedDRA
• Perform listedness assessment against product labels (for marketed products)
• Follow up on missing clinically significant information in consultation with medical staff
• Submit expedited reports to clients, regulatory authorities, ethics committees, investigators, and internal teams within timelines
• Assist with Periodic Safety Reports (PSRs) and Expedited Safety Reports (ESRs) submission
• Maintain project files, tracking systems, and safety study documentation
• Perform peer/quality review of processed reports and support trend analysis and CAPA development
• Support audits, inspections, and preparation of client meetings
• Train and mentor junior PSS staff and maintain cross-functional relationships
• Ensure compliance with SOPs, Work Instructions, Quality Management System, and regulatory requirements

Qualification:
• Non-degree + 2 yrs safety experience or 3–4 yrs relevant experience
• Associate degree + 2 yrs safety experience or 2–3 yrs relevant experience
• BS/BA + 1 yr safety experience or 2 yrs relevant experience
• MS/MA + 1 yr safety experience or 1–2 yrs relevant experience
• PharmD + 1 yr safety experience or 1–2 yrs relevant experience (Residency/Fellowship can count)

Experience:
• AE/SAE processing, writing narratives, generating queries, working with safety databases
• Regulatory submissions, PSRs, ESRs, and client reporting
• Relevant experience in Pharma/CRO/biotech in Clinical Data, Medical Affairs, Regulatory, QA, or related areas

Skills:
• Strong attention to detail and high degree of accuracy
• Good written and verbal communication skills
• Ability to work independently with minimal supervision and as a team player
• Proficiency in MS Office and standard office applications
• Training, mentoring, and presentation skills preferred

About the Organization:
Fortrea is a global life sciences services company providing high-quality clinical safety, regulatory, and PSS support to pharmaceutical and biotechnology clients.