Senior PV Data Analyst — Signal Detection & Reporting

Randstad Digital Americas

Duluth (GA)

On-site

USD 69,000 - 83,000

Full time

4 days ago
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Job summary

Randstad Digital Americas in Duluth, Georgia seeks a senior pharmacovigilance professional to lead PV signal detection and perform advanced data analysis to identify product safety trends.

You will develop monthly and quarterly trending reports, prepare safety datasets for regulatory inquiries, and collaborate with Marketing, QA, and external customers to deliver data-driven insights while supporting risk management activities across the organization.

Qualifications

  • Bachelor's degree in Life Sciences, Epidemiology, Statistics, or Information Systems.
  • 5+ years of dedicated experience working within pharmacovigilance, drug safety, or a highly regulated pharmaceutical environment.
  • Demonstrated expertise in advanced signal detection, risk management, and preparing aggregate safety reports.
  • Hands-on proficiency with industry-standard safety databases.
  • Strong programming and data visualization skills using SQL, SAS, R, or advanced Microsoft Excel.
  • Deep familiarity with standardized adverse event medical coding dictionaries.
  • Comprehensive understanding of global pharmacovigilance laws, regulatory guidelines, and reporting requirements.
  • Excellent technical writing skills for summarizing complex safety findings for cross-functional stakeholders.
  • High attention to detail and the ability to detect subtle safety trends in large datasets under strict deadlines.

Responsibilities

  • Perform pharmacovigilance signal detection and analysis to identify potential product safety trends.
  • Generate scheduled monthly and quarterly trending reports for product surveillance.
  • Perform custom data analysis and report generation for ad hoc requests regarding pharmacovigilance information.
  • Compile and analyze data to support requests from regulatory authorities and ensure strict compliance.
  • Provide data-driven insights and support for internal stakeholders (marketing, quality assurance) and external customers.
  • Contribute to broader product surveillance, safety risk assessments, and risk management activities.
  • Extract, analyze, and summarize relevant safety data using high-level computer literacy and Microsoft Office platforms.
  • Apply knowledge of epidemiology, statistics, and pharmacovigilance to ensure findings are accurate, reproducible, and inspection-ready.

Skills

advanced data analysis
data-driven insights
signal detection
Marketing
pharmacovigilance
Quality Assurance
surveillance
risk management
SQL
SAS
R
Microsoft Excel

Education

Bachelor's degree in Life Sciences, Epidemiology, Statistics, or Information Systems

Tools

Industry-standard safety databases

Job description

Randstad Digital Americas in Duluth, Georgia seeks a senior pharmacovigilance professional to lead PV signal detection and perform advanced data analysis to identify product safety trends.

You will develop monthly and quarterly trending reports, prepare safety datasets for regulatory inquiries, and collaborate with Marketing, QA, and external customers to deliver data-driven insights while supporting risk management activities across the organization.

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