Drug Safety Surveillance Analyst I

Job Title : Drug Safety Surveillance Analyst I
Location : Atlanta area locations (Athens, Johns Creek, Gainsville) or (St Joeseph, MO, or Ames, IA)
Type : 12 month contract
Compensation: $67-70/hour, depending on qualifications
Work Model : onsite
Hours : 40.0

Overview

Supports pharmacovigilance surveillance activities through signal detection, safety data analysis, reporting, and risk management support to ensure compliance with regulatory requirements and product safety monitoring.

Responsibilities

• Perform pharmacovigilance signal detection and analysis, including monthly and quarterly safety trending reports.
• Analyze safety data and generate reports to support regulatory authority requests and internal stakeholders, including Marketing, Quality, and external customers.
• Support product surveillance activities by monitoring and evaluating safety data for emerging trends and risks.
• Contribute to pharmacovigilance risk management initiatives and other post-market safety activities as required.

Requirements

• Fluent in written and spoken English.
• Knowledge of pharmacovigilance, epidemiology, statistics, or a related scientific discipline.
• Experience working in a highly regulated environment, such as pharmaceutical, biotechnology, or medical device industries.
• Proficient with Microsoft Office applications and safety data analysis tools.
• Experience generating safety reports, trend analyses, or regulatory support documentation.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #558-Scientific