Fortrea, a global contract research organization (CRO), is inviting applications for the position of Safety Science Specialist at its Pune location. This full-time opportunity is ideal for candidates with a background in pharmacy or life sciences and experience in pharmacovigilance and clinical safety operations.
🗓 Application Deadline: July 15, 2025
📍 Location: Pune, India
🕒 Job Type: Full-Time
🆔 Job Requisition ID: 253794
About the Role
The Safety Science Specialist will support clinical and post-marketing safety operations, focusing on the processing and management of adverse event reports. This includes ensuring timely submission to clients and regulatory authorities, maintaining safety databases, and contributing to periodic safety reports.
Key Responsibilities
- Process and manage adverse event (AE) and serious adverse event (SAE) reports from various sources.
- Enter safety data into databases and ensure quality and accuracy.
- Write patient narratives and code adverse events using MedDRA.
- Evaluate AE listedness against product labels (for marketed products).
- Identify and collect missing clinical information in collaboration with medical teams.
- Submit expedited reports to regulatory authorities, clients, ethics committees, investigators, and internal stakeholders as required.
- Support safety database reconciliation and generation of safety metrics.
- Maintain tracking systems and project documentation.
- Prepare data and support for audits, inspections, and safety review committees.
- Ensure compliance with SOPs, regulatory guidelines, and safety standards.
- Support CAPA development and root cause analysis when quality issues are identified.
Candidate Profile
Minimum Qualifications:
- PharmD, MPharm, or BPharm with at least 3 years of relevant experience.
- Background in Pharmacy, Nursing, Medical Sciences, or Life Sciences.
Preferred Skills & Experience:
- Hands-on experience with AE/SAE case processing and regulatory submissions.
- Proficiency in using safety databases and MS Office applications.
- Strong attention to detail and documentation skills.
- Good communication and presentation abilities.
- Ability to work independently and in team settings.
- Experience in training or mentoring is a plus.
Work Setting
- Office-based or remote work setup depending on business requirements.
Why Join Fortrea?
Fortrea offers a collaborative work environment where professionals are empowered to contribute to meaningful clinical research and safety operations. The organization values quality, innovation, and integrity, offering employees an opportunity to grow while making a global impact in healthcare.
Apply Now
If you’re ready to take the next step in your pharmacovigilance career, apply by July 15, 2025, and be part of a team dedicated to advancing patient safety and clinical excellence.
