Clinical Research Jobs 2025: Pharmacovigilance Jobs In Pune
Looking to advance your career in clinical safety and pharmacovigilance? Fortrea is hiring a Safety Science Coordinator II in Pune, open to PharmD, MPharm, and BPharm graduates with 2+ years of experience. This opportunity lies at the heart of global clinical operations, focusing on processing adverse event data, ensuring regulatory compliance, and contributing to public health through accurate safety reporting. With a dynamic team, cutting-edge systems, and a patient-first approach, Fortrea offers a powerful platform to grow your expertise in pharmacovigilance. Read on to learn more and apply now!
About the Company:
Fortrea is a leading global clinical research organization dedicated to providing end-to-end solutions in drug development, diagnostics, and therapeutic safety. Known for its innovation, compliance, and dedication to human health, Fortrea partners with pharmaceutical, biotech, and medical device companies to deliver clinical excellence across all phases of research. With a focus on data-driven pharmacovigilance and patient-centric trials, Fortrea ensures high-impact healthcare outcomes and regulatory integrity.
Job Details:
Job Title: Safety Science Coordinator II
Location: Pune
Category: Clinical
Job ID: 253907
Job Description
We are seeking a Safety Science Coordinator II to support our clinical research team in Pune. The ideal
candidate will have a background in safety science and a strong passion for ensuring the well-being of patients enrolled in clinical trials.Key Responsibilities
-
Process and manage adverse event (AE) reports from clinical trials or spontaneous sources as per client protocols.
-
Enter and review safety data in databases, ensuring accuracy, completeness, and readiness for expedited reporting.
-
Write patient narratives and code events using MedDRA; generate queries for missing clinical details when needed.
-
Ensure all safety cases receive timely medical review and are submitted to clients, regulators, and stakeholders within required timelines.
-
Handle Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs), including documentation and tracking.
-
Maintain study files, support reconciliation activities, and conduct quality/peer reviews of safety reports.
-
Train and mentor staff, contribute to status reports, and support metric tracking.
-
Follow SOPs, WIs, and pharmacovigilance guidelines; ensure full regulatory compliance.
-
Assist in audits, inspections, and client meetings as needed.
-
Perform other duties as assigned, based on the project or team requirements.
Qualifications
- A degree preferred in one or more of the following disciplines: Life Sciences, or a related area.
Keywords: Safety Science Coordinator, Clinical, Pune, Pharmacovigilance Jobs, Clinical Research Jobs 2025, Fortrea Job Openings Pune
