Safety Systems Analyst - Pharmacovigilance

Job Summary

Job Title Safety Systems Analyst I, Pharmacovigilance Safety Systems

Location Whitefield, Bangalore

Shift General

Job Description

This position is a member of Global Patient Safety (GPS) Safety Operations, Safety Systems and Data Management. The Safety Systems Analyst I serves as the Subject matter expert and is responsible for managing systems and databases to support consistent and accurate pharmacovigilance data collection, data analysis, report generation, and submission tracking.

The Safety Systems Analyst I acts as a technical subject matter expert responsible for managing routine to mediumcomplexity system requests, including updates to codelists, libraries, reports, dashboards, and reporting rules. The position works with internal GPS functional areas as well as vendor resources to review and implement routine to medium-complexity system changes, including updates to reporting rules.

This role is based in Whitefield, Bangalore, with periodic requirement to support global users across multiple time zones.

Qualifications

• Strong technical understanding of pharmacovigilance database systems.
• Excellent analytical and problem-solving skills.
• Strong knowledge of Pharmacovigilance system (e.g. ARGUS) with good understanding of the database structure and application architecture
• Strong technical system skills (e.g. Microsoft Office Tools, Power BI, SharePoint, SQL and Databases)
• Strong knowledge of pharmacovigilance terminology and understanding of data entry conventions
• Excellent oral and written communication skills with attention to detail
• Excellent interpersonal skills that encourage teamwork
• Ability to work independently under strict deadlines and changing priorities.
• Ability to multitask and prioritize changing workload for self and others on daily basis.
• Broad knowledge/understanding of relevant ICH guidelines, as well as global regulations (incl. FDA, EMA, PMDA,).
• Problem Solving- Identify priorities and key issues in complex situations and formulate and execute issue resolution with minimal assistance.