Job Title: Safety Science Analyst
Location: Pune
Company: Fortrea
Job Type: Full-time
Application Deadline: July 16, 2025
Job Requisition ID: 253633
Job Overview:
Fortrea is seeking a Safety Science Analyst to assist in clinical safety operations involving adverse event data processing across clinical trials and/or post-marketing scenarios. The role entails handling expeditable adverse events, ensuring accurate data entry, reporting, and compliance with regulatory timelines. This position is pivotal in supporting both internal and external clients with high-quality, cost-effective safety data services while adhering to global health and safety standards.
Key Responsibilities:
Triage and intake of safety reports from multiple sources (spontaneous or clinical trials).
Assist with processing adverse events, including:
Accurate data entry into safety tracking systems.
Drafting of patient narratives and MedDRA coding.
Listedness assessment against product labels.
Generating queries and coordinating with medical staff for information resolution.
Ensure timely submission of SAE reports to:
Clients
Regulatory authorities
Ethics committees
Investigators
Third-party vendors
Internal teams
Support in the submission of expedited and periodic reports to global agencies.
Participate in database reconciliation activities.
Adhere to Standard Operating Procedures (SOPs) and departmental work instructions.
Maintain and archive case/study/project documentation.
Build cross-functional relationships within the Pharmacovigilance Safety Services (PSS).
Ensure compliance with regulatory requirements and company standards.
Eligibility Criteria:
Education:
Non-degree holders with 6 months–1 year of safety or relevant experience.
Associate Degree: 0–6 months experience.
BS/BA: 0–6 months experience.
MS/MA/PharmD: No prior experience required.
Preferred Fields:
Biological Sciences
Pharmacy
Nursing
Medical Sciences
Life Sciences or related fields
Experience Definition:
Safety experience: Involvement with AE/SAE report processing, narrative generation, query handling, safety database work, and regulatory submissions.
Relevant experience: Work in pharmaceuticals, biotech, CROs, or departments like Medical Affairs, Data Entry/Management, Monitoring, Regulatory Affairs, or Quality Assurance.
Required Skills:
Strong attention to detail.
Effective team player with solid communication skills.
Proficient in MS Office and capable of handling standard office equipment.
Aptitude in numerical data proofing and accurate spelling.
Ability to work in an office or remote environment.
Work Environment:
Flexible to work in office-based or remote settings.
Must adhere to health and safety laws including COSHH and EC Directives.
Estimated Salary: ₹3.5–5 LPA (based on industry average for entry-level roles in Pune)
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