Pharmacovigilance Configuration Oversight Expert

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

• Support Safety Team during Audits & Inspections for providing Safety Data and Ad-hoc reports on urgency basis

• Analyze the impact of changes to the system not just limited to Upgrades, Config Changes, Introduction of new features, and any other potential changes to the PV System

• Implement relevant action items to mitigate any potential issues arising based on the Impact Analysis

• Responsible for PV System Configurations of PV database-

  • Clinical & Post marketed Studies

  • ​Company Products

  • Business user Roles & Data Privacy

  • Code Lists, Libraries, MedDRA, WHO

  • Distribution Rules

  • Accounts & HA Destinations

  • E2B Profiles

  • SDEA profiles & gateway

• Manage E2B gateway with Health authorities & Business Partners

• Implement 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 manager

• Hands-on in Case Processing to support the Business User for troubleshooting and problem solving

• Experience in configuration of Products, INNs, Salts and their variations, MedDRA Events

• Hands-on experience in dealing with Local Affiliates and understanding their Regulatory needs

• 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 5 years of pharmaceutical industry experience with a focus on pharmacovigilance

• Strong experience in Computer System Validation is required

• Incumbent should have hands-on in Process Improvement practices

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.

• 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:

• Regulatory Standards, Good Pharmacovigilance Practices (GxP), PV Configurations, Safety risk management, Safety Reporting Requirements.

• 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.

• Software Testing/Validation: Knowledge of user acceptance testing (UAT) for pharmacovigilance software and familiarity with data migration processes during system upgrades

• Good depth understanding of Quality Risk Management and Quality systems

Education:

Bachelor’s degree in pharmacy / Life Sciences / Engineering or equivalent Academic qualification is desirable with 5  years’ Technical Experience in GxP systems preferably in PV databases

Languages: Fluent in English (verbal and writt