Pharmacovigilance Configuration Analyst
India Permanent Posted on Apr. 15, 2025 Closing on Apr. 29, 2025Main responsibilities:
Manage the PV Configuration Standards, Distribution Rules, Study Configurations in LSMV, LSR & EV triage module
Perform User Accept Testing for Configuration Changes on behalf of the PV Systems Business Team
Work with Business Users to understand the Configuration changes and document them
Participate in updating training materials as releases move through the development and deployment process. Facilitate support and training sessions for system users
Work with Safety Team during Audits & Inspections for providing Safety Data and Ad-hoc reports on urgency basis
Responsible for PV System Configurations of PV database-
Company Products,
Clinical & Post marketed Studies
Business user Roles & Data Privacy
Code Lists, Libraries, MedDRA, WHO
Distribution Rules
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Accounts & HA Destinations
E2B Profiles
SDEA profiles & gateway
Maintain E2B gateway with Health authorities & Business Partners
Support Data Migration & Ingestion requests
Actively participate and contribute to the growing needs of Drug Safety PV Regulations
Support digital vendor teams in Configuration Changes needs, Testing & Deployments
Work with Business Users to understand the Configuration change needs and document them
Work in an Agile environment
About you
Experience:
- Experience in PV Databases like ARGUS, Aris-G, VAULT Safety, LSMV etc.
- Experience in a systems operations support role within Safety/pharmacovigilance as configuration analyst, configuration manage
- Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation
- Knowledge of IT systems in the pharmaceutical industry with an emphasis on PV systems
- Knowledge of validation processes
- Good knowledge of SQL, PL/SQL and MS Office
- Minimum 6-8 years’ pharmaceutical industry experience, experience in GxP systems preferably in PV databases with a focus on pharmacovigilance
- Strong experience in IS and validation is required
- Incumbent should have experience in Process Improvement practices
Safety Reporting Requirements: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards.
Soft skills:
Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions.
Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities.
Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams.
Experience in a CHC product and strategic development environment is essential. Previous experience leading a global organization including management of large multi-country budgets is essential.
Excellent team-work and interpersonal skills
Ability to work in cross-functional teams
Excellent oral and written communication skills
Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams.
Technical skills:
Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data.
Microsoft Office Suite: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings).
Business Intelligence Tools: Experience with tools like Power BI, or Spotfire to create visual reports and dashboards for stakeholders.
Software Testing/Validation: Knowledge of user acceptance testing (UAT) for pharmacovigilance software and familiarity with data migration processes during system upgrades
Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way
Cross-functional Communication: Ability to collaborate with various departments (e.g., clinical, medical affairs, regulatory) and effectively communicate data insights and recommendations.
Education:
Scientific background: Bachelor’s degree in pharmacy / Life Sciences / Engineering or equivalent Academic qualification is desirable
Languages: Fluent in English (verbal and written)
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