🔬 About Fortrea
Fortrea is a global Contract Research Organization (CRO) at the forefront of advancing healthcare solutions through cutting-edge clinical trials, drug safety monitoring, and regulatory compliance services. We collaborate with some of the world’s most innovative pharmaceutical, biotech, and medical device companies to bring breakthrough therapies to patients in need.
With a mission rooted in quality, innovation, and patient-centric values, Fortrea offers a dynamic and inclusive environment for professionals looking to make a global impact in the healthcare sector.
📅 Application Process
🌐 Organization: Fortrea – A Global Leader in Clinical Research
📍 Location: Pune, India (Hybrid Work Model)
🕒 Job Type: Full-time | Entry-Level
⏳ Application Deadline: July 7, 2025 (Apply ASAP – Only a few days left!)
Position Overview: Safety Science Coordinator I
As a Safety Science Coordinator I, you will play a critical role in supporting pharmacovigilance and drug safety operations. This entry-level opportunity is ideal for science graduates passionate about ensuring the safety of investigational and marketed products. You’ll work within a global team to process safety data, manage adverse event (AE/SAE) reports, and ensure timely submission of regulatory safety documents.
Key Responsibilities
🔹 Expedited & Periodic Safety Reporting
• Assist in the preparation, review, and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) to global regulatory agencies in accordance with local and international guidelines.
🔹 Adverse Event (AE/SAE) Management
• Receive, log, process, and track AE/SAE reports in compliance with company SOPs and regulatory requirements (e.g., FDA, EMA, ICH-GCP).
🔹 Data Entry & Documentation
• Accurately enter safety data into pharmacovigilance databases.
• Generate follow-up queries, track case status, and support in narrative writing for patient case summaries.
🔹 Regulatory Compliance
• Ensure activities align with global PV standards and Good Pharmacovigilance Practices (GVP).
• Maintain up-to-date knowledge of safety reporting guidelines and regulations.
🔹 Quality Control & Review
• Perform peer reviews and quality checks on safety reports.
• Participate in database reconciliations and audits to ensure data integrity.
🔹 Training & Collaboration
• Provide support and guidance to junior staff when required.
• Coordinate with cross-functional teams including medical writing, clinical operations, and regulatory affairs.
Eligibility & Qualifications
Minimum Required Education & Experience:
| Education Level | Relevant Experience Required |
| Non-Degree | 1–2 years of relevant experience |
| Associate Degree | 6 months – 1 year |
| Bachelor’s / Master’s / Pharm.D | 0–6 months up to 1 year |
Preferred Educational Background:
• B.Pharm, M.Pharm, Pharm.D, BSc/MSc in Life Sciences, Nursing, Medical Sciences, Biotechnology, or related fields.
Preferred Experience (any of the following):
• Hands-on exposure to pharmacovigilance operations, especially handling AE/SAE reports
• Familiarity with MedDRA coding, case processing, and safety database management
• Experience in Clinical Data Management, Regulatory Affairs, or working in the pharma/biotech industry
Key Skills Required
✔ Excellent verbal and written communication skills (English and local language)
✔ Strong attention to detail with a focus on accuracy
✔ Proficiency in MS Office tools (Excel, Word, Outlook)
✔ Familiarity with pharmacovigilance or clinical trial software/safety databases (preferred)
✔ Ability to manage multiple priorities, meet deadlines, and work effectively in a team
Why Join Fortrea?
🌍 Hybrid Work Flexibility – Balance office and remote work seamlessly
📈 Professional Growth – Clear career progression within a reputable global CRO
🏥 Health & Safety Compliant – In line with COSHH and European Directives
🤝 Inclusive Work Culture – Fortrea is an Equal Opportunity Employer (EEO) and provides reasonable accommodations
Application Process
🗓 Deadline to Apply: July 7, 2025
⏰ Note: Applications are being reviewed on a rolling basis. Early applicants may receive interview calls sooner. Don’t miss out!
🔗 How to Apply: Visit the official Fortrea careers page or Click on this: Apply now
If you are looking to launch your career in pharmacovigilance, clinical research, or regulatory sciences, this is a perfect stepping stone into the global pharmaceutical industry. Fortrea empowers its employees to innovate, grow, and contribute meaningfully to global health.
Start your journey with Fortrea – Where science meets safety.
