Job Title: Safety Science Coordinator I
Location: Pune, India
Category: Clinical
Job ID: 254799
About Fortrea
Fortrea is a leading global Contract Research Organization (CRO) with decades of clinical development experience. Operating in ~100 countries, we provide comprehensive clinical development and technology solutions to pharmaceutical, biotechnology, and medical device customers across more than 20 therapeutic areas. Our mission is to accelerate the delivery of life-changing therapies through scientific rigor, collaboration, and innovation.
Our culture—Fortrea FOUR—focuses on Forward Together, Own It, Uphold Integrity, and Respect People. Join our team to grow professionally and make a meaningful global impact.
Visit: www.fortrea.com
Job Overview
As a Safety Science Coordinator I, you will assist with Clinical Safety and/or Pharmacovigilance and Safety Surveillance (PSS) operations related to products, including the management of adverse events from clinical trials and post-marketing settings. You will handle expedited adverse event reports, ensuring timely submission to clients and regulatory authorities while maintaining quality and compliance.
Key Responsibilities
Assist with processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs), including tracking and submission to clients, regulatory bodies, ethics committees, and investigators.
Maintain adverse event tracking systems and project documentation files.
Log and forward incoming Adverse Event (AE) and Serious Adverse Event (SAE) reports appropriately.
Enter safety data into tracking systems accurately.
Write patient narratives and accurately code adverse events using MedDRA for marketed products (if applicable).
Assist with label assessment (“listedness”) for marketed products.
Generate queries for missing or discrepant information, in consultation with medical staff.
Submit expedited SAE reports within agreed timelines to all relevant stakeholders, including clients and regulatory authorities.
Support peer and quality reviews of reports, assist with trend analysis and related actions.
Reconcile databases as needed and maintain filing for adverse event reporting requirements across countries.
Operate within the Quality Management System (QMS), adhering to SOPs and departmental work instructions.
Prepare and coordinate safety study files for archiving upon project completion.
Schedule and arrange internal/external meetings or teleconferences.
Train and mentor PSS assistants and peers in daily activities.
Build and maintain positive relationships across functional teams.
Ensure compliance with regulatory requirements and project-specific plans.
Provide administrative support to PSS personnel.
Perform other duties as assigned.
Qualifications
Education
BPharm, MPharm, or PharmD degree preferred.
Fortrea may consider equivalent education or relevant experience in lieu of formal qualifications.
Experience
Minimum 2 years of relevant safety experience*, or experience in pharmaceutical/CRO industry**.
*Safety experience includes processing AE/SAE reports, generating narratives, working with safety databases, and regulatory submissions.
**Relevant experience includes pharmaceutical or CRO industry roles.
Skills and Competencies
Strong team player with ability to support peers effectively.
Ability to prioritize and manage multiple tasks efficiently.
Keen attention to detail.
Good written and verbal communication skills in English and local language.
Strong logical thinking and proofreading skills, with comfort handling numerical data.
Proficient keyboard skills and familiarity with MS Office and Windows environments beneficial.
Ability to operate standard office equipment.
Work Environment
Office-based role in Pune.
Equal Employment Opportunity & Accessibility
Fortrea is committed to providing equal employment opportunities and reasonable accommodations to individuals with disabilities throughout the application and employment process.
How to Apply
To receive tailored job alerts or share this opportunity, visit Fortrea’s careers page or sign up for email alerts.
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