Fortrea, a leading global organization in clinical research and pharmacovigilance, is currently hiring for 5 critical positions in Pune and Mumbai. If you are passionate about safety science, regulatory operations, and pharmacovigilance, this is your chance to join a dynamic team. Below, we have outlined the job details, responsibilities, and application deadlines for each role. Read on to find the perfect opportunity for you!
1. Safety Science Coordinator I
Location: Pune
Job Requisition ID: 251048
Application Deadline: March 6, 2025 (1 day left to apply)
Key Responsibilities:
- Assist in processing Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain adverse event tracking systems and project files.
- Ensure timely reporting of adverse events to clients, regulatory authorities, and ethics committees.
- Data entry of safety data and coding adverse events using MedDRA.
- Support quality review of processed reports and assist in database reconciliation.
- Train and mentor PSS Assistants and peers.
- Ensure compliance with regulatory requirements and SOPs.
2. Safety Science Coordinator II
Location: Pune
Job Requisition ID: 251060
Application Deadline: March 6, 2025 (1 day left to apply)
Key Responsibilities:
- Process adverse event reports from clinical trials and spontaneous sources.
- Review adverse events for completeness, accuracy, and expedited reporting.
- Write patient narratives and code adverse events using MedDRA.
- Ensure timely submission of Serious Adverse Event (SAE) reports to regulatory authorities.
- Maintain study-level documentation and support database reconciliation.
- Assist in client meetings and quality issue management.
3. Safety Science Specialist
Location: Pune
Job Requisition ID: 251067
Application Deadline: March 6, 2025 (1 day left to apply)
Key Responsibilities:
- Manage receipt and processing of adverse event reports from clinical trials and spontaneous sources.
- Perform data entry and review adverse events for expedited reporting.
- Ensure timely submission of SAE reports to regulatory authorities and clients.
- Assist in database reconciliation and maintain adverse event tracking systems.
- Support root cause analysis and CAPA plan development for quality issues.
- Participate in audits and inspections as needed.
4. Senior Regulatory Operations Specialist I
Location: Pune (Hybrid)
Job Requisition ID: 25145
Application Deadline: March 8, 2025 (3 days left to apply)
Key Responsibilities:
- Prepare and review CMC (Chemistry, Manufacturing, and Controls) documents for global product registrations.
- Coordinate with cross-functional teams for change control evaluation and documentation.
- Support global labeling projects, stability data evaluation, and regulatory submissions.
- Manage import/export licenses and ensure compliance with regulatory guidelines.
- Train and mentor junior staff and maintain high-quality standards in regulatory operations.
Apply Now: Senior Regulatory Operations Specialist I
5. Senior Regulatory Operations Specialist III
Location: Mumbai (Hybrid)
Job Requisition ID: 2447502
Application Deadline: March 8, 2025 (3 days left to apply)
Key Responsibilities:
- Review and approve raw materials and formulations for compliance with global regulations.
- Evaluate formulations for new product development and marketed products.
- Prepare impact assessments for formulation changes and support new ingredient submissions.
- Ensure compliance with REACH, DEG/EG, Nitrosamine, and ICHQ3D guidelines.
- Review packaging material changes and prepare technical justifications for stability testing.
Apply Now: Senior Regulatory Operations Specialist III
Why Join Fortrea?
Fortrea is a global leader in clinical research and pharmacovigilance, offering:
- Opportunities to work on cutting-edge projects in safety science and regulatory operations.
- A collaborative and inclusive work environment.
- Career growth and development opportunities.
- Competitive compensation and benefits.
How to Apply
Don’t miss this opportunity to join Fortrea! Click on the respective job titles above to apply. Ensure you submit your application before the deadline:
Apply Now: Safety Science Coordinator I
Apply Now: Safety Science Coordinator II
Apply Now: Safety Science Specialist
Apply Now: Senior Regulatory Operations Specialist I
Apply Now: Senior Regulatory Operations Specialist III
