Fortrea, a leading global Contract Research Organization (CRO), is inviting applications for the position of Safety Science Coordinator I at its Pune location. This is an excellent opportunity for freshers and early-career professionals seeking to build a career in pharmacovigilance, clinical safety, and adverse event management within a regulated global environment.
The role involves hands-on exposure to AE/SAE processing, expedited safety reporting, MedDRA coding, regulatory submissions, and safety database management for clinical trial and post-marketing products.
Key Responsibilities – Safety Science Coordinator I
As a Safety Science Coordinator I at Fortrea, you will support clinical safety and patient safety services (PSS) operations, including:
- Processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs)
- Logging and tracking Adverse Events (AE) and Serious Adverse Events (SAE)
- Writing patient narratives and coding events using MedDRA
- Supporting listedness assessments against reference safety information
- Submitting SAE reports to regulatory authorities, ethics committees, investigators, and clients
- Maintaining safety databases and tracking systems
- Generating and following up on safety queries
- Supporting quality review, reconciliation, and audit readiness
- Assisting in SOP and Work Instruction compliance
- Coordinating meetings, teleconferences, and safety documentation
- Training and mentoring junior PSS staff
- Supporting archiving of safety study files
This role demands strong attention to detail, regulatory awareness, and effective cross-functional collaboration.
Qualifications & Eligibility Criteria
Fortrea considers education and relevant industry experience flexibly for this role.
Educational Background (Any One):
- PharmD (0–6 months safety experience or residency/fellowship)
- MS / MA in Life Sciences or related fields
- BS / BA in Pharmacy, Biological Sciences, Nursing, Medical or Life Sciences
- Associate Degree with relevant experience
- Non-degree candidates with 1–2 years of safety or related CRO experience
Relevant Experience Includes:
- Pharmacovigilance / Drug Safety
- Clinical Data Management (CDM)
- Clinical Data Entry or Monitoring
- Regulatory Affairs
- Quality Assurance
- Medical Affairs
- CRO or Pharmaceutical Industry exposure
Required Skills:
- Knowledge of AE/SAE processing and safety databases
- Good written and verbal communication (English + local language)
- Strong attention to detail and data accuracy
- Ability to manage multiple priorities
- Proficiency in MS Office and Windows
- Team-oriented mindset with quality focus
Why Join Fortrea?
- Global exposure in clinical safety and pharmacovigilance
- Structured learning in regulatory compliance and safety operations
- Career growth in drug safety, PV operations, and clinical research
- Work with international clients and regulatory agencies
- Competitive compensation aligned with CRO industry standards
Salary Details (Estimated)
- ₹4,00,000 – ₹6,50,000 per annum (based on qualifications and experience)
Salary is indicative and may vary.
Job Location & Work Mode
- Location: Pune, Maharashtra
- Work Mode: Office / Hybrid (project-dependent)
- Job Type: Full-time
Application Process
