Pharmacovigilance Jobs at Fortrea | Apply Now for Safety Science Coordinator Role

Are you looking for a career in pharmacovigilance and clinical safety operations? Fortrea is hiring a Safety Science Coordinator I for a hybrid position in Pune, India. This role offers an excellent opportunity to work on adverse event reporting, regulatory submissions, and safety data management while supporting global clinical trials and marketed products.

About Fortrea

Fortrea is a leading global contract research organization (CRO) committed to advancing healthcare innovation. With expertise in clinical development and safety operations, Fortrea partners with top pharmaceutical and biotechnology companies to deliver solutions that prioritize patient safety, regulatory compliance, and data integrity.

Job Details

• Job Title: Safety Science Coordinator I
• Location: Pune, India (Hybrid)
• Employment Type: Full-time
• Job Requisition ID: 253818

Qualifications

• PharmD / M.Pharm / B.Pharm with at least 1 year of relevant experience.
• Degree preferred in Pharmacy, Nursing, Medical Sciences, Life Sciences, or related areas.
• Prior safety experience in AE/SAE processing, narrative writing, database handling, and regulatory submissions.
• Equivalent experience in Medical Affairs, Clinical Data Management, Regulatory Affairs, or Quality Assurance may also be considered.
• Proficiency in English (speaking, reading, writing) and the local language.

Skills & Experience

• Strong teamwork and collaboration abilities.
• Ability to prioritize and manage multiple tasks.
• Excellent attention to detail with logical and numerical data handling skills.
• Strong communication skills (written and verbal).
• Proficiency in MS Office and standard office equipment.

Job Overview

As a Safety Science Coordinator at Fortrea, you will support clinical safety and pharmacovigilance operations for clinical trials and post-marketing safety activities. You will assist in processing adverse events, managing safety databases, and ensuring regulatory compliance while maintaining high standards of quality and accuracy.

Key Responsibilities

• Assist in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
• Maintain adverse event tracking systems and ensure accurate documentation.
• Manage setup and maintenance of the project and central files.
• Process incoming Adverse Event (AE) / Serious Adverse Event (SAE) reports, including data entry, MedDRA coding, patient narratives, and listedness assessments.
• Generate queries for missing or discrepant information and liaise with medical staff as needed.
• Submit SAE reports to clients, regulatory authorities, ethics committees, and other stakeholders within agreed timelines.
• Perform peer/quality reviews of processed reports and assist in the reconciliation of databases.
• Work within the Quality Management System framework, ensuring adherence to SOPs and regulatory standards.
• Train and mentor PSS Assistants or peers on day-to-day tasks.
• Support project coordination, archiving, and administrative safety operations.

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