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Lead Safety Science Specialist

Fortrea
2+ years
Not Disclosed
Bangalore, India
2 May 21, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes

Lead Safety Science Specialist

Company: Fortrea
Job Title: Lead Safety Science Specialist
Job ID: 262138
Location: Bengaluru, Karnataka
Job Category: Clinical Safety / Pharmacovigilance / Drug Safety
Employment Type: Full-time


Job Summary

Fortrea is hiring a Lead Safety Science Specialist to support Clinical Safety and Pharmacovigilance operations across clinical trial and post-marketing safety activities. The role involves adverse event case processing, expedited reporting, pharmacovigilance documentation, signal detection, regulatory submissions, and mentoring junior safety staff.


Key Responsibilities

  • Manage adverse event (AE) and serious adverse event (SAE) case processing from clinical trials and post-marketing sources.

  • Perform:

    • Safety database entry

    • AE review

    • Medical coding

    • Patient narrative writing

    • Follow-up for missing case information

    • Label/listedness assessment

  • Handle expedited SAE submissions to:

    • Regulatory Authorities

    • Ethics Committees

    • Investigators

    • Clients

    • Third-party vendors

    • Project teams

  • Ensure compliance with global reporting timelines.

  • Prepare pharmacovigilance reports including:

    • ICSRs

    • Annual IND Reports

    • Annual Safety Reports (ASRs)

    • DSUR

    • Periodic Reports

    • Aggregate Safety Reports

  • Perform peer quality checks (QC) of safety reports.

  • Support safety database reconciliation with Data Management teams.

  • Assist in:

    • Signal detection

    • Trend analysis

    • Pattern recognition

  • Monitor workflow timelines for assigned studies/programs.

  • Support development of:

    • SOPs

    • Work Instructions

    • Safety Management Plans

    • Reconciliation Plans

  • Participate in client meetings and project discussions.

  • Support audit and inspection readiness.

  • Assist Drug Safety Monitoring Boards (DSMBs) and safety committees.

  • Train and mentor junior pharmacovigilance staff.


Required Qualifications

Educational Qualification
Accepted backgrounds:

  • Biological Sciences

  • Pharmacy

  • Nursing

  • Medical Sciences

  • Life Sciences

  • Related healthcare disciplines

Minimum qualification combinations:

  • Non-degree + 2–3 years safety experience / 5 years relevant experience

  • Associate degree + 2–3 years safety experience

  • BS/BA + 2 years safety experience

  • MS/MA + 2 years safety experience

  • PharmD + 2 years safety experience


Required Experience

  • Minimum 2+ years in Pharmacovigilance / Drug Safety

  • Experience in:

    • Clinical safety case processing

    • ICSR management

    • SAE reporting

    • Aggregate safety reporting

    • Regulatory safety submissions