Pharmacovigilance (PV) Data Analyst V

In this role, you will lead routine pharmacovigilance (PV) signal detection and perform advanced data analysis to proactively identify and evaluate product safety trends. Core responsibilities include developing comprehensive monthly and quarterly trending reports for ongoing product surveillance, as well as executing targeted data analyses to fulfill custom ad hoc requests. Furthermore, you will prepare precise safety datasets to directly support regulatory authority inquiries and partner with cross-functional stakeholders-such as Marketing, Quality Assurance, and external customers-to provide essential data-driven insights. Through these efforts, you will actively contribute to broader product safety surveillance strategies and essential risk management activities., * 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.

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

Experience Requirements

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.

Technical & Analytical Skills

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.

Regulatory Knowledge & Soft Skills

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.

skills:

advanced data analysis,data-driven insights,proactively,signal detection,Marketing,pharmacovigilance,Quality Assurance,surveillance,risk management