Fortrea Hiring Freshers for Pharmacovigilance / Clinical Safety in Pune. Apply now before October 28, 2025.
Company: Fortrea
Position: Safety Science Coordinator I
Location: Pune, Maharashtra
Job Type: Full-Time
Experience Required: 0–2 Years
Application Deadline: October 28, 2025 (6 hours left to apply)
Job Requisition ID: 255490
Status: Verified Job
About Fortrea
Fortrea is a leading global contract research organization (CRO) providing comprehensive drug development, clinical research, and pharmacovigilance solutions to top pharmaceutical and biotechnology companies. The company’s mission is to advance patient safety, regulatory compliance, and medical innovation through cutting-edge data management and global expertise. Fortrea Hiring Freshers for Pharmacovigilance / Clinical Safety
Fortrea’s Safety Science Coordinator I position in Pune is designed for individuals passionate about clinical safety, pharmacovigilance operations, and adverse event data management. Fortrea Hiring Freshers for Pharmacovigilance / Clinical Safety
Job Overview
The Safety Science Coordinator I will assist with Clinical Safety and Pharmacovigilance operations, ensuring proper handling, assessment, and submission of adverse event (AE) and serious adverse event (SAE) reports. The role involves working closely with global safety teams to maintain compliance with regulatory and client requirements while supporting ongoing clinical and post-marketing safety activities. Fortrea Hiring Freshers for Pharmacovigilance / Clinical Safety
Key Responsibilities
- Assist in the processing and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain adverse event tracking systems and ensure all AE/SAE reports are accurately logged and updated.
- Support the set-up and maintenance of project and central files for documentation.
- Assist in the data entry of safety information and case details into tracking systems.
- Write patient narratives and code events using MedDRA terminology.
- Support listedness assessments and generate queries for missing or inconsistent information.
- Submit SAE reports to clients, regulatory authorities, ethics committees, investigators, and other partners within required timelines.
- Conduct peer and quality reviews of processed reports to ensure compliance with SOPs.
- Participate in database reconciliation and maintenance of adverse event reporting files.
- Coordinate study file archiving, meeting scheduling, and communication activities.
- Provide training and mentoring to PSS Assistants and team members as needed.
- Ensure adherence to Quality Management System (QMS), SOPs, and work instructions.
- Maintain operational compliance with applicable safety and regulatory standards (Health and Safety at Work Act, COSHH, EC Directives).
Qualifications
Candidates may qualify through education or relevant experience as described below: Fortrea Hiring Freshers for Pharmacovigilance / Clinical Safety
- Non-Degree: 1–2 years of safety or relevant experience.
- Associate Degree: 6 months–1 year of safety experience.
- Bachelor’s (BS/BA): 0–1 year of safety experience.
- Master’s (MS/MA): 0–6 months of safety experience.
- Pharm.D: 0–6 months of safety experience (1-year residency/fellowship considered relevant).
Preferred Disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related areas.
Safety Experience Includes:
- AE/SAE case processing
- Narrative writing
- Data entry and query management
- Safety database use (e.g., Argus, ARISg)
- Regulatory submission activities
Relevant Experience Includes:
Clinical data management, monitoring, medical affairs, regulatory affairs, or quality assurance roles in the pharmaceutical, biotech, or CRO industry. Fortrea Hiring Freshers for Pharmacovigilance / Clinical Safety
Required Skills and Competencies
- Strong attention to detail and accuracy.
- Excellent written and verbal communication skills in English and local language.
- Good team collaboration and peer support abilities.
- Capable of handling multiple priorities efficiently.
- Proficiency in MS Office and familiarity with clinical databases.
- Logical thinking and strong proofreading skills, especially for numerical data.
- Good keyboard and office equipment handling skills.
Work Environment
- Mode: Office-based or remote (depending on company policy).
- Department: Pharmacovigilance / Patient Safety Services (PSS).
- Reporting To: Project Lead / PSS Manager.
Why Join Fortrea?
- Opportunity to work with a global leader in clinical research and pharmacovigilance.
- Exposure to international drug safety regulations and reporting systems.
- Structured career development and continuous training programs.
- Collaborative, inclusive, and performance-driven work culture.
- Competitive compensation and professional growth opportunities.
How to Apply
Interested candidates are encouraged to apply immediately through the official Fortrea careers portal before October 28, 2025.
Equal Opportunity Statement
Fortrea is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination based on race, color, religion, gender, sexual orientation, national origin, disability, or veteran status. Fortrea Hiring Freshers for Pharmacovigilance / Clinical Safety
Conclusion
The Safety Science Coordinator I role at Fortrea offers an excellent entry point for professionals looking to build a career in pharmacovigilance and clinical safety. With global exposure, structured learning, and opportunities for growth, this position is ideal for candidates passionate about ensuring patient safety and advancing medical innovation. Fortrea Hiring Freshers for Pharmacovigilance / Clinical Safety
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