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Patient Safety Project Manager at Fortrea - ApplyBlast

Patient Safety Project Manager

Fortrea

4 months ago

3.5 on Glassdoor

São Paulo, Brazil

Hybrid

Full Time

Senior

0 applicants

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About this role

A Senior Pharmacovigilance or Project Safety Specialist drives the management of adverse events and safety data for clinical trials and post-marketing settings. The role involves ensuring compliant reporting to regulatory agencies, processing expedited safety reports, and leading global project operations within the pharmaceutical industry. Success requires deep knowledge of pharmacovigilance regulations, safety databases, and collaboration with medical staff and clients to maintain data quality.

Responsibilities

Manage end-to-end adverse event processing for clinical and post-marketing data
Ensure compliant expedited safety reporting to global regulatory authorities
Lead global project workflows to meet strict safety timelines and deadlines
Review and code adverse events using industry-standard terminologies
Supervise team members and mentor less experienced colleagues on safety protocols

Skills

Qualifications

BS in Biological SciencesBS in PharmacyBS in NursingPharmDEudraVigilance Certification

About Fortrea

fortrea.com

Headquarters

Lake Park, North Carolina, United States

Company Size

10001+ employees

View Profile

Fortrea, a leading CRO, advancing clinical trials through patient-focused clinical solutions that accelerate clinical development, drive trial success, and bring innovative therapies to those who need them most.