Senior Safety Science Specialist Job – at Fortrea, Apply Now!
Fortrea is hiring a Senior Safety Science Specialist in Pune to support global pharmacovigilance and clinical safety operations. This role focuses on adverse event management, regulatory submissions, and compliance with international safety standards. If you have relevant experience in processing AE/SAE reports, safety data management, and clinical documentation, this is your opportunity to contribute to drug safety on a global scale.
- Job Posting: Senior Safety Science Specialist
- Location: Pune
- Job requisition ID: 252177
About The Company
Fortrea is a global leader in clinical research services and pharmacovigilance. Through cutting-edge technologies and expert teams, we ensure data integrity, patient safety, and regulatory compliance. At Fortrea, we prioritize diversity, inclusion, and continuous growth in the life sciences industry.
Job Overview:
Fortrea is seeking a Senior Safety Science Specialist to assist with global pharmacovigilance operations, including clinical and post-marketing safety data management. This role ensures the accurate collection, processing, and reporting of adverse events in compliance with global regulatory standards.
Senior Safety Science Specialist Job – Key Responsibilities:
- Manage the receipt and processing of adverse event reports from clinical trials and spontaneous sources.
- Enter safety data into adverse event databases and track system entries.
- Author patient narratives and code events using MedDRA.
- Perform regulatory assessments, determine listedness, and ensure follow-up for incomplete reports.
- Submit expedited safety reports to regulatory authorities, clients, and investigators within timelines.
- Reconcile safety databases with data management teams and ensure documentation accuracy.
- Support the preparation of PSURs, DSURs, Annual IND Reports, and regulatory filings.
- Conduct quality reviews, supported CAPA implementation, and participated in safety audits.
- Assist in preparing data for DSMBs and regulatory inspections.
- Mentor junior staff and ensure SOP compliance across safety reporting workflows.
Senior Safety Science Specialist Job – Qualifications:
- Bachelor’s, Master’s, or PharmD in Life Sciences, Pharmacy, Nursing, or related fields.
- 2+ years of hands-on experience in AE/SAE case processing and regulatory reporting.
- Familiarity with GCP, ICH Guidelines, and worldwide safety regulations.
- Knowledge of safety databases and medical terminology.
- Excellent communication, accuracy, and teamwork skills.
Keywords: Clinical Safety, Job Opportunity, Adverse Events Process, Regulatory Reporting, Medical Affairs, Clinical Data Management, Pharmaceutical Industry.
