Fortrea is a leading global contract research organization (CRO) that partners with biopharmaceutical, biotechnology, and medical device companies to drive healthcare innovation. With a strong commitment to quality and compliance, Fortrea provides comprehensive clinical development and commercialization services to accelerate the delivery of life-changing therapies to patients worldwide.
Join Fortrea’s dynamic team in Pune and contribute to advancing drug safety and pharmacovigilance while working in a collaborative and growth-oriented environment.
Job Overview
The Senior Safety Science Specialist will assist in Clinical Safety and Pharmacovigilance (PSS) operations, managing adverse event (AE) reporting from clinical trials and post-marketing surveillance. This role ensures compliance with regulatory requirements, timely submission of safety reports, and high-quality pharmacovigilance services for clients.
Key Responsibilities
Adverse Event Management
- Process and manage expeditable adverse event reports from clinical trials and post-marketing sources.
- Perform data entry into safety databases, ensuring accuracy and completeness.
- Review AE reports for expedited reporting compliance.
- Write patient narratives and code AEs using MedDRA.
- Assess listedness against product labels (for marketed products).
- Identify missing clinical data and ensure follow-up.
Regulatory Reporting
- Submit Serious Adverse Event (SAE) reports to regulatory agencies, clients, and investigators within required timelines.
- Conduct database reconciliation with Data Management teams.
- Assist in preparing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
Compliance & Quality Assurance
- Maintain adverse event tracking systems and project documentation.
- Support signal detection, trend analysis, and risk assessment.
- Assist in preparing IND Annual Reports, PSURs, DSURs, and other regulatory documents.
- Conduct peer reviews and ensure quality control in safety reporting.
Training & Leadership
- Mentor junior safety staff in case handling and pharmacovigilance processes.
- Participate in client meetings, audits, and inspections.
- Contribute to root cause analysis (RCA) and CAPA implementation.
Additional Duties
- Support Drug Safety Monitoring Boards (DSMBs) and endpoint committees.
- Assist in study file archiving post-project completion.
- Stay updated with SOPs, ICH Guidelines, and GCP standards.
Qualifications & Experience
Minimum Education & Experience Required:
| Education Level | Safety Experience* | Relevant Experience** |
|---|---|---|
| Non-degree + 2 years | 2 years | 4-5 years |
| Associate degree + 2 years | 2 years | 3-4 years |
| BS/BA + 1-2 years | 1-2 years | 2-3 years |
| MS/MA + 1-2 years | 1-2 years | 2 years |
| PharmD + 1-2 years | 1-2 years | 2 years |
Safety Experience: Processing AE/SAE reports, narratives, safety databases, regulatory submissions.
Relevant Experience: Pharmaceutical, biotechnology, CRO, Medical Affairs, Clinical Data Management, Regulatory Affairs, or QA.
Preferred Disciplines:
- Biological Sciences
- Pharmacy
- Nursing
- Medical/Life Sciences
Skills & Competencies
✔ Strong attention to detail & accuracy
✔ Excellent written & verbal communication
✔ Knowledge of medical & drug terminology
✔ Familiarity with GCP, ICH Guidelines, global regulatory requirements
✔ Proficiency in MS Office & safety databases
✔ Ability to work independently & mentor junior staff
Work Environment & Physical Demands
- Office-based role in Pune
- Minimal travel (5%) as per project needs
