Pharmacovigilance Configuration Analyst

Main 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

• 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)