Safety Science Coordinator - II
Fortrea · Karnātaka, India
SafetyFull timeCompany career page
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Fortrea seeks a Safety Science Coordinator II to manage adverse event reports and clinical safety operations for pharmaceutical products. The role involves processing safety data from clinical trials and post-marketing sources, ensuring regulatory compliance, and submitting reports to clients and agencies within established timelines.
What they're looking for
- Bachelor's degree or higher in biological sciences, pharmacy, nursing, or related field
- 1+ years safety or relevant experience (depending on education level)
- High accuracy and attention to detail with strong organizational skills
- Proficiency in MS Office and Windows applications
- Excellent written and verbal communication abilities
- Ability to work independently with moderate supervision
- MedDRA coding knowledge preferred
What you'll be doing
- Process and manage adverse event reports from clinical trials and post-marketing sources according to client-agreed protocols
- Enter safety data into databases, review for completeness and accuracy, and determine expedited reporting requirements
- Write patient narratives, code adverse events, and identify missing clinical information by consulting medical staff
- Submit expedited safety reports to regulatory authorities, ethics committees, and study personnel within specified timelines
- Maintain project documentation, support quality reviews, and assist with staff training and mentoring
Privacy & handoff
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