Senior Safety Specialist FSP
Core
Perform day-to-day Pharmacovigilance (PV) activities including data entry, coding, assessment of adverse events, case review, follow-up, tracking, and regulatory reporting to ensure patient safety.
Role type
Senior Safety Specialist (Pharmacovigilance)
Builds
Regulatory safety reports and PV case files for pharmaceutical and biotech clients
Domain
Life Sciences / Pharmaceutical / Regulatory Compliance
Required skills
Pharmacovigilance case management, Adverse event assessment, Regulatory reporting, Data quality review, Therapeutic area knowledge, Audit preparation, Procedure development, Stakeholder coordination, Critical thinking, Time management
Preferred skills
Medical understanding of pathophysiology, Experience with Clinical Trials committees, Mentorship of junior staff
Technologies
Microsoft Office (Outlook, Word, Excel), Multiple safety databases
Responsibilities
Collect, monitor, assess, evaluate, research, and track safety information; Review cases for quality, consistency, and accuracy; Prepare and maintain regulatory safety reports; Coordinate project implementation and attend client/investigator meetings; Assist in preparing departmental procedures and processes; Mentor less experienced staff.
Seniority
Senior, hands-on IC with mentorship responsibilities