Safety Science Coordinator II – Fortrea, Pune
Location: Pune, India
Employment Type: Full-time
Salary/Compensation: Not specified
Job Summary
Fortrea is hiring a Safety Science Coordinator II to manage pharmacovigilance operations, adverse event reporting, and clinical safety data. This role involves processing safety reports, maintaining regulatory compliance, and supporting global drug safety activities. Ideal candidates will have a strong background in pharmacy, medical sciences, or life sciences with experience in MedDRA coding and pharmacovigilance processes.
Key Responsibilities
Process adverse event (AE) reports from all sources per client or sponsor requirements.
Manage receipt, data entry, and tracking of AEs in safety databases.
Review safety data for completeness, accuracy, and expedited reporting needs.
Write patient narratives and perform MedDRA coding for adverse events.
Conduct causality assessments and follow-up on missing clinical information.
Ensure timely submission of expedited safety reports (ESRs) and periodic safety reports (PSRs) to clients and regulatory authorities.
Maintain and reconcile safety data in project databases and tracking systems.
Support audits, inspections, and quality reviews of processed reports.
Assist with preparation for client meetings and provide regular safety metrics and status reports.
Mentor team members and provide training on pharmacovigilance processes.
Required Skills & Qualifications
PharmD, MPharm, or BPharm with 2+ years of pharmacovigilance experience.
Degree in Pharmacy, Nursing, Medical Sciences, Life Sciences, or related disciplines.
Strong attention to detail and accuracy in safety data entry and narrative writing.
Proficiency in MedDRA coding and ICSR processing.
Knowledge of GVP, ICH guidelines, and clinical trial safety processes.
Good written and verbal communication skills.
Ability to work independently with moderate supervision.
Proficiency in MS Office applications; mentoring experience preferred.
Perks & Benefits
Opportunity to work with a global CRO with expertise in over 20 therapeutic areas.
Exposure to international pharmacovigilance and safety operations.
Collaborative and inclusive workplace culture.
Career growth and continuous learning opportunities.
Company Description
Fortrea is a leading global contract research organization (CRO) with a strong focus on drug safety, clinical development, and medical device solutions. Operating across 100+ countries, Fortrea is committed to delivering innovative solutions and accelerating the development of life-changing therapies for patients worldwide.
Work Mode: On-site (Pune, India)
Call-to-Action
Ready to advance your pharmacovigilance career? Apply now for the Safety Science Coordinator II role at Fortrea and be part of a global team dedicated to clinical excellence.
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