Fortrea is a leading global contract research organization (CRO) specializing in clinical development and patient safety solutions. With a strong commitment to advancing healthcare, Fortrea partners with pharmaceutical, biotechnology, and medical device companies to deliver high-quality clinical trial management, pharmacovigilance, and regulatory compliance services.
Job Openings at Fortrea Pune
Fortrea is currently hiring for two key roles in Pharmacovigilance and Drug Safety in Pune:
1. Senior Safety Science Specialist
Job ID: 252177
Job Overview
The Senior Safety Science Specialist will assist in Clinical Safety and Pharmacovigilance (PSS) operations, managing adverse event (AE) reporting from clinical trials and post-marketing surveillance. The role ensures compliance with global regulatory requirements and timely submission of safety reports.
Key Responsibilities
- Process and manage AE/SAE reports from clinical trials and post-marketing sources.
- Perform data entry, MedDRA coding, and narrative writing.
- Ensure expedited reporting to regulatory agencies within required timelines.
- Conduct database reconciliation and support signal detection activities.
- Assist in preparing Periodic Safety Reports (PSURs, DSURs).
- Train and mentor junior safety staff.
- Maintain compliance with SOPs, ICH-GCP, and global pharmacovigilance regulations.
Qualifications
- Education: Degree in Life Sciences, Pharmacy, Nursing, or related field.
- Experience:
- Non-degree + 2 years of safety experience OR 4-5 years of relevant experience.
- BS/BA + 1-2 years of safety experience OR 2-3 years in pharmacovigilance, clinical research, or regulatory affairs.
- Skills: Strong attention to detail, knowledge of MedDRA, GCP, and regulatory reporting.
2. Safety Science Coordinator II
Job ID: 251946
Job Overview
The Safety Science Coordinator II supports pharmacovigilance operations by processing adverse event reports, ensuring compliance with regulatory timelines, and maintaining safety databases.
Key Responsibilities
- Process AE/SAE reports and perform data entry in safety databases.
- Review reports for completeness and accuracy.
- Assist in expedited and periodic safety reporting (ESRs, PSRs).
- Support database reconciliation and quality checks.
- Maintain documentation and assist in audits/inspections.
- Follow SOPs and regulatory guidelines (ICH, GCP).
Qualifications
- Education: Degree in Biological Sciences, Pharmacy, or related field.
- Experience:
- 1-2 years in pharmacovigilance, clinical data management, or regulatory affairs.
- Skills: Knowledge of MedDRA, medical terminology, and safety databases.
Why Join Fortrea?
- Work with a global leader in clinical research.
- Career growth in pharmacovigilance and drug safety.
- Training and mentorship opportunities.
- Collaborative work environment with industry experts.
How to Apply
Application Link for Senior Safety Science Specialist
Application Link for Safety Science Coordinator II
Application Deadline: June 10, 2025 (3 days left to apply)
