Job Title: Safety Science Coordinator II – Pune (On-site)
Location: Pune, India
Category: Clinical & Pharmacovigilance
Company: Fortrea
Work Mode: On-site
Experience Required: 2+ years
Salary: Not specified
Job Summary
Fortrea is hiring a Safety Science Coordinator II for its Pune office. This role focuses on end-to-end adverse event processing, safety report submissions, and pharmacovigilance compliance. Ideal for candidates with 2+ years of experience in pharmacovigilance, this role ensures regulatory safety reporting, documentation, and collaboration across clinical and post-marketing safety operations.
Key Responsibilities
Process and manage adverse event reports from various sources.
Perform data entry, tracking, and case assessment for completeness and accuracy.
Write patient narratives and code AEs using MedDRA.
Generate queries for missing clinical information; consult with medical reviewers when needed.
Prioritize and submit expedited safety reports (ESRs) to clients and regulatory authorities within timeline requirements.
Assist in database reconciliation, quality review, and documentation.
Support reporting of periodic safety reports (PSRs).
Train and mentor team members as needed.
Maintain compliance with SOPs, regulatory guidelines, and pharmacovigilance best practices.
Contribute to audit and inspection readiness.
Required Skills & Qualifications
Education: PharmD, MPharm, BPharm (preferred disciplines: Pharmacy, Life Sciences, Nursing, or Medical Sciences).
Experience: Minimum 2 years in pharmacovigilance or clinical safety roles.
Strong knowledge of adverse event processing, MedDRA coding, and safety databases.
Proficient in MS Office; accurate data entry and documentation.
Good verbal and written communication skills.
Ability to work independently and in cross-functional teams.
Familiarity with ICH-GCP, local regulatory requirements, and case reporting timelines.
Perks & Benefits
Work with a global leader in clinical trials and pharmacovigilance.
Exposure to both clinical trial and post-marketing safety reporting.
Professional development in regulatory safety and drug monitoring.
Supportive team culture with peer mentorship opportunities.
Stable and structured work environment.
Company Overview
Fortrea is a global clinical research and drug development company providing advanced solutions across the pharmaceutical and healthcare industries. With a focus on compliance, safety, and data-driven clinical excellence, Fortrea supports life sciences innovation from early development to post-marketing surveillance.
Work Mode
On-site – Pune, India
Call to Action
Are you ready to advance your career in clinical safety and pharmacovigilance? Apply today for the Safety Science Coordinator role and join a global team committed to improving drug safety and patient outcomes.
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