Apply for Fortrea Hiring for Safety Science Coordinator I Pune. Start your career in pharmacovigilance, drug safety, and regulatory operations today.
Introduction
Fortrea, a global leader in clinical research and biopharmaceutical development, is seeking qualified professionals for the position of Safety Science Coordinator I in Pune, India. This full-time opportunity is designed for individuals interested in contributing to drug safety, pharmacovigilance, and regulatory compliance within the clinical research industry. Fortrea Hiring for Safety Science Coordinator I
The Safety Science Coordinator I plays a vital role in ensuring that adverse events (AEs) and serious adverse events (SAEs) from both clinical trials and post-marketing studies are accurately recorded, processed, and reported in compliance with global regulatory standards.
This role offers a chance to gain in-depth experience in safety data management and to collaborate with global teams in a dynamic, fast-paced environment that emphasizes quality, compliance, and patient safety. Fortrea Hiring for Safety Science Coordinator I
About Fortrea
Fortrea is a world-renowned Contract Research Organization (CRO) that supports the biopharmaceutical industry in developing life-saving drugs and medical innovations. The company is driven by a mission to advance healthcare by combining scientific expertise, technology-driven insights, and operational excellence. Fortrea Hiring for Safety Science Coordinator I
Fortrea’s team of safety science professionals plays a critical role in ensuring the ethical and accurate handling of drug safety data, making it an ideal environment for professionals passionate about pharmacovigilance and clinical safety. Fortrea Hiring for Safety Science Coordinator I
Job Title:
Safety Science Coordinator I
Location: Pune, India
Job Type: Full-Time
Department: Pharmacovigilance and Patient Safety (PSS)
Application Deadline: October 31, 2025
Job Overview
The Safety Science Coordinator I will assist in managing the clinical safety and pharmacovigilance operations related to various pharmaceutical products. The position involves supporting the end-to-end adverse event reporting process, including data collection, entry, analysis, and submission to clients and regulatory authorities.
The primary goal of this role is to ensure the accuracy, compliance, and timeliness of safety data submissions while maintaining the highest quality standards. Fortrea Hiring for Safety Science Coordinator I
Key Responsibilities
1. Safety Data Processing
- Assist with processing and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Enter adverse event data into tracking systems accurately and efficiently.
- Write patient narratives and ensure that adverse events are coded correctly using MedDRA (Medical Dictionary for Regulatory Activities).
- Perform listedness assessments for marketed products to determine if events are consistent with known safety profiles.
- Fortrea Hiring for Safety Science Coordinator I
2. Regulatory Submissions and Documentation
- Submit expedited SAE reports to clients, regulatory agencies, ethics committees, investigators, partners, and project personnel within the agreed timelines.
- Maintain up-to-date adverse event tracking systems and ensure documentation accuracy.
- Assist in database reconciliation between safety systems and other data management tools.
- Support the preparation of study safety files for archiving upon project completion.
3. Quality Assurance and Compliance
- Work within Fortrea’s Quality Management System (QMS), adhering to Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).
- Support quality review of processed reports to ensure compliance with company and regulatory standards.
- Participate in trend analysis, audit preparation, and process improvement initiatives.
4. Communication and Collaboration
- Collaborate with internal teams, regulatory departments, and clients to ensure efficient safety reporting processes.
- Maintain strong professional relationships within the Patient Safety Services (PSS) team and across departments.
- Schedule and organize meetings, teleconferences, and project-related discussions as required.
- Fortrea Hiring for Safety Science Coordinator I
5. Training and Mentorship
- Train and mentor junior staff or peers in daily pharmacovigilance operations.
- Continuously update personal knowledge on safety databases, regulatory reporting guidelines, and clinical safety practices.
6. Administrative and Support Activities
- Manage and organize project documentation, trackers, and records.
- Ensure compliance with Health and Safety at Work Act (1974), COSHH Regulations (1989), and EC Directives (1992/3) as applicable.
- Provide administrative support to the Patient Safety Services team and assist with ad-hoc safety activities as assigned.
Qualifications and Educational Requirements
Fortrea values both formal education and hands-on experience in the field of pharmacovigilance, drug safety, and clinical research.
Minimum Educational Qualifications:
- Non-Degree holders: 1–2 years of safety experience or relevant equivalent experience.
- Associate Degree: 6 months to 1 year of safety experience or relevant equivalent.
- Bachelor’s Degree (BS/BA): 0–6 months to 1 year of safety experience or related field.
- Master’s Degree (MS/MA): 0–6 months of relevant safety experience.
- PharmD: 0–6 months of experience, including residency or fellowship experience that can be considered relevant.
Preferred Fields of Study:
- Biological Sciences
- Pharmacy
- Nursing
- Medical Sciences
- Life Sciences
- Related areas of study
Relevant Experience
Safety Experience Includes:
- Processing AE/SAE reports
- Writing and reviewing patient narratives
- Query management for data discrepancies
- Working within pharmacovigilance databases
- Preparing and submitting regulatory safety reports
Relevant Experience Includes:
- Roles in pharmaceutical, biotechnology, or CRO sectors in areas such as:
- Clinical Data Management
- Clinical Data Entry and Monitoring
- Medical Affairs
- Regulatory Affairs
- Quality Assurance
Fortrea also considers relevant and equivalent experience in lieu of specific educational requirements. Fortrea Hiring for Safety Science Coordinator I
Required Skills and Attributes
- Excellent written and verbal communication skills in English and local language.
- Strong attention to detail with good logical reasoning and analytical thinking.
- Ability to handle multiple priorities and meet strict deadlines.
- Team player with the ability to offer peer support and collaboration.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
- Good keyboarding skills and familiarity with Windows-based environments.
- Aptitude for working with and proofreading numerical and narrative data.
- Commitment to maintaining data integrity and quality standards.
- Ability to adapt to a changing work environment and manage workload effectively.
Physical Demands and Work Environment
- Primary work setting: Office-based or remote (as per project needs).
- Must be able to operate standard office equipment such as computers and telephones.
- Expected to maintain compliance with company safety guidelines and environmental protocols.
Why Join Fortrea?
At Fortrea, you’ll become part of a global organization that values innovation, collaboration, and scientific excellence. The company provides opportunities to work on impactful projects that contribute to public health and patient safety. Fortrea Hiring for Safety Science Coordinator I
Key Benefits:
- Work on global pharmacovigilance and safety projects.
- Gain expertise in international safety reporting and regulatory operations.
- Be part of a supportive, knowledge-driven environment.
- Competitive compensation and opportunities for career advancement.
- Access to continuous learning, mentorship, and internal growth programs.
Career Growth Opportunities
Starting as a Safety Science Coordinator I, you can build a long-term career in pharmacovigilance and drug safety. With experience and skill enhancement, professionals can progress to roles such as: Fortrea Hiring for Safety Science Coordinator I
- Safety Science Coordinator II
- Drug Safety Associate
- Pharmacovigilance Specialist
- Safety Project Manager
- Senior Safety Scientist
Application Process
Interested candidates should apply through the Fortrea Careers Portal before October 31, 2025. Ensure your resume clearly demonstrates relevant safety experience, pharmacovigilance exposure, or transferable skills from clinical research roles.
Applicants may also be required to undergo an assessment or interview focusing on pharmacovigilance knowledge, attention to detail, and compliance awareness. Fortrea Hiring for Safety Science Coordinator I
Conclusion
The Safety Science Coordinator I role at Fortrea Pune is an excellent opportunity for fresh graduates or early-career professionals aiming to build a strong foundation in drug safety and pharmacovigilance. This position combines scientific rigor with regulatory excellence, making it ideal for individuals passionate about improving patient safety through accurate and compliant data management. Fortrea Hiring for Safety Science Coordinator I
If you’re ready to take the next step in your clinical research career and contribute to a safer healthcare environment, apply now and become part of Fortrea’s global mission to advance medical innovation responsibly. Fortrea Hiring for Safety Science Coordinator I
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