Job Summary
Fortrea, a global leader in Contract Research Organization (CRO) services, is hiring a Senior Safety Science Specialist for its Pune location. This role focuses on the complete management of adverse event reporting, safety data processing, and regulatory compliance for clinical and post-marketing safety projects. Ideal for professionals experienced in pharmacovigilance, drug safety databases, and clinical trial safety monitoring, this role offers the chance to work across diverse therapeutic areas within a globally recognized CRO.
Key Responsibilities
Manage receipt and processing of adverse event reports from all sources including spontaneous and clinical trial data.
Perform data entry, adverse event coding (MedDRA), and write detailed patient narratives.
Conduct completeness, accuracy, and seriousness reviews for expedited regulatory submissions.
Handle SAE reports submission to clients, regulators, and other stakeholders within defined timelines.
Maintain and reconcile safety databases and ensure proper tracking of safety data.
Support periodic safety reporting (PSUR, DSUR) and assist in preparation of cumulative reports.
Participate in signal detection, trend analysis, and early risk identification activities.
Mentor and train junior safety staff on safety case handling and reporting procedures.
Perform quality checks, peer reviews, and ensure SOP and GVP compliance.
Support audits, inspections, and safety file management, contributing to CAPA plans.
Required Skills & Qualifications
Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or a related field.
Minimum of 2 years of pharmacovigilance/safety experience or 4-5 years of related industry experience.
Proficiency in adverse event processing, narrative writing, safety databases, and regulatory submissions.
Strong knowledge of ICH-GCP guidelines, clinical trial safety documentation, and worldwide pharmacovigilance regulations.
Excellent verbal and written English communication skills.
High attention to detail, ability to work independently with minimal supervision.
Familiarity with MS Office, Windows, and database tools.
Perks & Benefits
On-site role at Fortrea’s Pune office.
Opportunity to work with cutting-edge drug safety technology and global clinical trials.
Career development through mentorship and exposure to complex pharmacovigilance systems.
Be part of an internationally recognized CRO with broad therapeutic area expertise.
Company Description
Fortrea is a leading global CRO delivering full-spectrum clinical development and technology solutions across more than 20 therapeutic areas. Operating in over 100 countries, Fortrea transforms drug and device development for pharmaceutical, biotechnology, and medical device industries with a strong focus on scientific integrity and regulatory compliance.
Work Mode
On-site (Pune, India)
Call-to-Action
Elevate your career in clinical safety science with Fortrea. Apply now for the Senior Safety Science Specialist position and make a global impact in pharmaceutical safety and clinical research.
Gujarat :
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