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Location: Bangalore, India
Job ID: 254811
Application Deadline: September 11, 2025
Employment Type: Full-time
Fortrea, a leading global CRO, is inviting applications for the role of Safety Science Coordinator I. This position plays a critical role in supporting clinical safety operations and ensuring compliance with regulatory requirements across clinical trials and post-marketing settings.
Key Responsibilities
- Assist in processing and submitting Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) to clients, regulatory authorities, ethics committees, and investigators.
- Maintain adverse event tracking systems and project documentation.
- Manage the intake, data entry, and accurate coding of Adverse Events (AEs) and Serious Adverse Events (SAEs) using MedDRA.
- Prepare patient narratives and perform listedness assessments for marketed products.
- Generate safety queries and collaborate with medical staff for data collection.
- Support database reconciliation and quality review of reports.
- Ensure compliance with SOPs, Work Instructions, and global regulatory standards.
- Provide administrative support and mentoring to junior staff when required.
Qualifications
Candidates must meet one of the following:
- Non-Degree with 1–2 years of safety or relevant experience
- Associate Degree with 6 months–1 year of safety or relevant experience
- Bachelor’s (BS/BA) with 0–1 year of safety or relevant experience
- Master’s (MS/MA) with 0–6 months of safety or relevant experience
- PharmD with 0–6 months of safety or relevant experience (Residency/Fellowship can be considered)
Preferred Fields of Study: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related areas.
Relevant experience includes roles in Medical Affairs, Clinical Data Entry/Management, Monitoring, Regulatory Affairs, or Quality Assurance.
Skills & Competencies
- Strong attention to detail and logical thinking.
- Good communication skills in English and local language.
- Ability to manage multiple priorities and meet strict timelines.
- Proficiency in MS Office, Windows, and safety databases.
- Team-oriented, with the ability to provide peer support and mentorship.
⏳ Don’t miss this opportunity! Applications close on September 11, 2025.
👉 Interested candidates should apply directly via Fortrea’s careers portal.
