Fortreaย is a leading global contract research organization (CRO) specializing in clinical development and patient access solutions. With a strong commitment to advancing healthcare, Fortrea supports pharmaceutical, biotechnology, and medical device companies in bringing innovative treatments to market.
Detailed Job Description
Job Title: Safety Science Coordinator I
๐ Location: Mumbai (Full-Time)
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Application Deadline: July 12, 2025
๐ Job Requisition ID: 253758
Key Responsibilities:
โ Expedited & Periodic Safety Reports: Assist in processing and submitting ESRs/PSRs to regulatory agencies within deadlines.
โ Adverse Event Management: Log, track, and process AE/SAE reports, ensuring accurate data entry and MedDRA coding.
โ Regulatory Compliance: Ensure adherence to global safety reporting requirements (FDA, EMA, etc.).
โ Quality Checks: Support peer reviews, database reconciliations, and compliance with SOPs.
โ Training & Support: Mentor junior staff and collaborate with cross-functional teams.
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Eligibility & Qualifications
Minimum Required Education & Experience:
- Non-Degree:ย 1-2 years of safety/relevant experience
- Associate Degree:ย 6 months – 1 year of experience
- BS/BA, MS/MA, or PharmD:ย 0-6 months to 1 year of experience
Preferred Disciplines:
- Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences
Required Skills:
โ
Team collaboration & multitasking
โ
Strong attention to detail
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Proficient in MS Office & safety databases
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Excellent English + local language skilll
Benefits & Work Environment
๐ Work Setup: Office-based or remote options
๐ Career Growth: Training & mentorship programs
๐ผ Industry Exposure: Work with global regulatory submissions
โ๏ธ Compliance Focus: Adherence to Health & Safety standards (COSHH, EC Directives)
How to Apply
