Drug Safety Surveillance Analyst I

System One; Duluth (GA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health coverage

401(k) plan

Job summary

System One is seeking a Drug Safety Surveillance Analyst I for an onsite contract role in Johns Creek, GA. The role focuses on pharmacovigilance signal detection, data analysis, and generation of routine safety reports.

You will work in a regulated environment, use Microsoft Office, and collaborate with stakeholders to support regulatory submissions and risk management.

Qualifications

• Fluent in written and spoken English.
• Knowledge of pharmacovigilance, epidemiology, statistics or related field.
• Experience working in a highly regulated environment.
• High level of computer literacy and fluent in Microsoft Office platforms.

Responsibilities

• Performs Pharmacovigilance signal detection and analysis including generation of monthly and quarterly trending reports.
• Performs data analysis and report generation for ad hoc requests for PV information to support regulatory authority requests and stakeholder support (marketing, quality, external customers, etc.).
• Contributes to other PV product surveillance and risk management activities as needed.

Skills

Fluent in English written and spoken

Pharmacovigilance knowledge

Epidemiology or statistics knowledge

Experience in regulated environment

Microsoft Office proficiency

Tools

Microsoft Office

Job description

Job Title: Drug Safety Surveillance Analyst I
Location: Johns Creek, GA
Type: Contract
Work Model: onsite
Hours: 40.0

Responsibilities

• Performs Pharmacovigilance signal detection and analysis including generation of monthly and quarterly trending reports.
• Performs data analysis and report generation for ad hoc requests for PV information to support regulatory authority requests and stakeholder support (marketing, quality, external customers, etc.).
• Contributes to other PV product surveillance and risk management activities as needed
• Pharmacovigilance signal detection and analysis including generation of monthly and quarterly trending reports.
• Performs data analysis and report generation for ad hoc requests for PV information to support regulatory authority requests and stakeholder support (marketing, quality, external customers, etc.).
• Contributes to other PV product surveillance and risk management activities as needed.

Requirements

• Fluent in written and spoken English
• Knowledge of pharmacovigilance, epidemiology, statistics or related field.
• Experience working in a highly regulated environment
• High level of computer literacy and fluent in Microsoft Office platforms

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.