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-
- 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
- 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 written)