Job Title: Pharmacovigilance Configuration Analyst
Location: India
Job Type: Permanent
Posted on: April 15, 2025
Closing Date: April 29, 2025
Experience Required: 6–8 years
Qualifications: Bachelor's degree in Pharmacy, Life Sciences, Engineering, or equivalent
Languages Required: Fluent in English (verbal and written)
Job Description:
The Pharmacovigilance Configuration Analyst will manage the PV (Pharmacovigilance) Configuration Standards, Distribution Rules, and Study Configurations within various safety systems. This role involves performing User Acceptance Testing (UAT), working with business users to understand configuration changes, and supporting the safety team during audits and inspections. Additionally, the analyst will manage data migration requests, system validation, and the E2B gateway with health authorities and business partners.
Key Responsibilities:
Manage PV System Configurations including company products, clinical and post-marketed studies, and safety data.
Support Safety Team during audits and inspections, providing safety data and ad-hoc reports.
Collaborate with stakeholders to understand and document configuration changes.
Perform User Acceptance Testing for configuration changes and support testing and deployments in an Agile environment.
Maintain and manage E2B profiles, safety database configurations, and distribution rules.
Contribute to regulatory compliance for safety reporting (e.g., CIOMS forms, EudraVigilance).
Participate in the development and update of training materials.
Experience and Skills:
Pharmacovigilance Databases: Familiarity with systems like ARGUS, Aris-G, VAULT Safety, LSMV, etc.
Safety Reporting: Knowledge of regulatory safety reporting requirements (e.g., CIOMS forms, EudraVigilance, FDA REMS).
Technical Skills:
SQL/PLSQL for database management.
Microsoft Office: Advanced Excel, Word, PowerPoint.
Business Intelligence: Experience with tools like Power BI or Spotfire.
Systems Operations Support: Experience in safety/pharmacovigilance system configuration and management.
Soft Skills: Strong communication, stakeholder management, and problem-solving skills.
Validation Processes: Experience in GxP systems validation.
Required Qualifications:
Educational Background: Bachelor's degree in Pharmacy, Life Sciences, Engineering, or equivalent.
Experience: 6–8 years in the pharmaceutical industry, with a focus on GxP systems and pharmacovigilance.
Language: Fluent in English (both written and verbal).
About Sanofi:
Sanofi is committed to advancing human health and providing equal opportunities to all individuals. The company values diversity and fosters a collaborative environment where innovation can thrive.
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