Specialist I – Clinical Safety / Pharmacovigilance | Bangalore, India
Company: Fortrea
Location: Bangalore, Karnataka, India
Employment Type: Full-Time
Job ID: 26731
Application Deadline: 30 April 2026
About Fortrea
Fortrea is a global Contract Research Organization (CRO) delivering clinical development and pharmacovigilance solutions to pharmaceutical, biotechnology, and medical device companies. With a strong focus on regulatory compliance, data integrity, and patient safety, Fortrea supports sponsors across the full product lifecycle from clinical trials to post-marketing surveillance.
Position Overview
The Specialist I – Clinical Safety supports end-to-end pharmacovigilance and safety operations, including adverse event (AE) and serious adverse event (SAE) case processing across clinical trial and post-marketing settings. This role ensures accurate safety data management, regulatory compliance, and timely submission of expedited safety reports to global regulatory authorities and clients.
The position is suited for professionals with hands-on experience in pharmacovigilance case processing, safety databases, and global regulatory reporting.
Key Responsibilities
Adverse Event Case Processing
Manage receipt, assessment, and processing of spontaneous and clinical trial AE/SAE reports.
Perform data entry into safety databases and tracking systems.
Review cases for completeness, medical accuracy, and expedited reporting requirements.
Draft clear and accurate patient narratives.
Code adverse events using MedDRA terminology.
Assess listedness against approved product labeling (for marketed products).
Identify missing clinically significant information and initiate follow-up activities.
Regulatory Reporting and Compliance
Ensure timely submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, and partners.
Process and/or review Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
Support preparation of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Annual IND reports.
Maintain adverse event tracking systems and project documentation files.
Ensure compliance with ICH guidelines, GCP standards, and worldwide regulatory requirements.
Quality and Reconciliation
Perform database reconciliation with Data Management teams or sponsors.
Conduct peer review and quality review of safety reports.
Support root cause analysis and CAPA plan development.
Assist with audit and inspection readiness activities.
Signal Detection and Aggregate Reporting
Participate in signal detection, trend analysis, and pattern recognition activities.
Assist in review of cumulative safety data for submission to DSMBs, regulatory authorities, or clients.
Project Support and Mentorship
Contribute to monthly status reports and project-specific metrics.
Support and mentor junior safety staff in case handling and reporting processes.
Participate in client meetings and cross-functional project discussions.
Assist with Safety Management Plans (SMPs) and reconciliation plans.
Prepare safety study files for archiving upon project completion.
Educational Qualifications
Candidates must meet one of the following criteria:
Non-degree qualification with 2 years of Safety experience or 4–5 years of relevant industry experience.
Associate degree with 2 years of Safety experience or 3–4 years of relevant experience.
Bachelor’s degree (BS/BA) with 1–2 years of Safety experience or 2–3 years of relevant experience.
Master’s degree (MS/MA) with 1–2 years of Safety experience or 2 years of relevant experience.
PharmD with 1–2 years of Safety experience or 2 years of relevant experience.
(A one-year residency or fellowship may be considered relevant experience.)
Preferred academic disciplines include:
Biological Sciences
Pharmacy
Nursing
Medical Sciences
Life Sciences
Related healthcare fields
Equivalent relevant experience may be considered in lieu of formal education.
Experience Required
1–3 years of hands-on pharmacovigilance or clinical safety experience.
Direct experience processing AE/SAE reports, narrative writing, MedDRA coding, and regulatory submissions.
Knowledge of ICH guidelines and Good Clinical Practice (GCP).
Familiarity with global adverse event reporting requirements for investigational and marketed products.
Experience in pharmaceutical, biotechnology, or CRO environments preferred.
Key Skills and Competencies
Strong attention to detail and data accuracy.
Good written and verbal communication skills.
Ability to work independently with minimal supervision.
Strong teamwork and collaboration skills.
Knowledge of medical and drug terminology.
Proficiency in MS Office and Windows-based systems.
Ability to manage multiple priorities under strict timelines.
Work Environment
Office-based role in Bangalore.
Approximately 5% travel, including overnight stays as required by project needs.
Compliance-driven and quality-focused pharmacovigilance environment.
Equal Opportunity Statement
Fortrea is committed to equal employment opportunity and fostering a diverse and inclusive workplace. All qualified applicants will be considered in accordance with applicable laws and regulations.
Explore the latest Pharmacovigilance, Clinical Safety, Regulatory Affairs, and CRO career opportunities at ThePharmaDaily.com.
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