Safety Science Coordinator I
📍 Location: Pune, India
🖥 Work Type: Hybrid (Office + Remote)
📅 Application Deadline: July 7, 2025
🆔 Job Requisition ID: 253691
💼 Employment Type: Full-Time
Fortrea, a global leader in clinical trial services and drug development, is looking for dynamic candidates to join its team as Safety Science Coordinator I. This role is an excellent opportunity for individuals aiming to build a career in pharmacovigilance and clinical safety within a professional and compliance-driven environment.
🔍 Job Overview
As a Safety Science Coordinator I, you will support the Pharmacovigilance & Safety Services (PSS) team in managing adverse event processes and regulatory submissions. You’ll assist in processing safety reports, handling data entries, narrative writing, and communicating with stakeholders—all while ensuring compliance with international regulatory requirements.
🧪 Key Responsibilities
- Assist in the management of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain accurate records in adverse event tracking systems.
- Process incoming AE/SAE reports and ensure timely forwarding to the centralized mailbox.
- Draft patient narratives and perform MedDRA coding (for marketed products if applicable).
- Conduct listedness assessments against product labels.
- Generate and follow up on queries for missing or discrepant data.
- Submit SAE reports to regulatory bodies, ethics committees, and clients.
- Participate in the quality review of processed reports.
- Contribute to database reconciliation and ensure compliance with SOPs.
- Support in organizing meetings and training new team members.
- Ensure all tasks meet regulatory timelines and client expectations.
🎓 Eligibility Criteria
Candidates must fulfill at least one of the following educational or experience-based requirements:
- Non-degree holders with 1–2 years of safety or relevant industry experience.
- Associate degree with 6 months to 1 year of safety/relevant experience.
- Bachelor’s degree (BS/BA) in Pharmacy, Life Sciences, or related areas with 0–1 year experience.
- Master’s degree (MS/MA) or PharmD with 0–6 months experience.
Note: For PharmD holders, a one-year residency or fellowship can be considered relevant experience.
🛠 Skills & Competencies Required
- Strong attention to detail and organizational skills.
- Ability to manage multiple tasks and deadlines effectively.
- Proficient in English and local language (both written and spoken).
- Knowledge of MS Office and adverse event tracking systems.
- Understanding of pharmacovigilance concepts and regulatory compliance.
- Team-oriented, adaptable, and proactive in peer training and support.
🏢 Work Environment
This is a hybrid role, offering flexibility between working from home and the office. You’ll be part of a supportive, regulated, and globally connected environment focused on patient safety and data quality.
📨 How to Apply
Interested candidates should apply by July 7, 2025.
Use Job Requisition ID 253691 to apply on the official Fortrea careers portal or reach out to HR for more information.
🔗 Apply here: www.fortrea.com/careers
Begin your journey in clinical safety with Fortrea — where innovation meets integrity.
