Fortrea is a leading global contract research organization (CRO) committed to advancing healthcare through innovative clinical research and pharmacovigilance solutions. With a strong focus on patient safety and regulatory compliance, Fortrea partners with pharmaceutical, biotechnology, and medical device companies to bring life-changing therapies to market.
At Fortrea, we foster a collaborative work environment where professionals can grow their careers while contributing to meaningful advancements in medical science.
Job Description
Job Overview
The Safety Science Coordinator II will assist in Clinical Safety and Pharmacovigilance (PSS) operations, including adverse event (AE) processing from clinical trials and post-marketing reports. The role involves ensuring compliance with regulatory requirements, timely submissions, and maintaining high-quality safety data.
Key Responsibilities
- Process adverse event reports from clinical trials and post-marketing sources.
- Perform data entry, review AEs for completeness, and ensure accurate MedDRA coding.
- Generate patient narratives and assess cases for expedited reporting.
- Submit Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) to regulatory agencies, clients, and investigators.
- Maintain tracking systems and project documentation.
- Assist in database reconciliation and quality review processes.
- Support training and mentoring of PSS staff.
- Ensure compliance with SOPs, Work Instructions, and regulatory guidelines (e.g., FDA, EMA, ICH-GCP).
- Assist in audit/inspection preparation and client meetings.
Qualifications & Experience
Minimum Required:
- Non-degree + 1 year of Safety experience OR 3 years of relevant experience.
- Associate degree + 1 year of Safety experience OR 2 years of relevant experience.
- BS/BA + 1 year of relevant experience.
- MS/MA + 1 year of relevant experience.
- PharmD + 1 year of relevant experience (residency/fellowship counts).
Preferred Degrees:
- Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related fields.
Skills & Competencies:
- High attention to detail and accuracy.
- Strong written and verbal communication skills.
- Ability to work independently and in a team.
- Proficiency in MS Office, safety databases, and pharmacovigilance tools.
- Knowledge of MedDRA coding and regulatory reporting timelines.
