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
- undefined
- 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
Requirements :
- Scientific background: Bachelor’s degree in pharmacy / Life Sciences / Engineering or equivalent Academic qualification is desirable
- Languages: Fluent in English (verbal and written)
- Minimum 6-8 years’ pharmaceutical industry experience, experience in GxP systems preferably in PV databases with a focus on pharmacovigilance
- 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
- 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.
- 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.
- 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.