Senior Specialist, PV Global Safety database

• Configure and maintain Safety and Medical information database.
• Manage user accounts, roles, and access controls.
• Perform routine system checks and maintenance tasks.
• Provide support during system implementation and post-go-live phases.
• Act as first-level support for database-related issues via the internal helpdesk tool.
• Troubleshoot and resolve technical issues in collaboration with IT and vendor teams.
• Assist in the creation and execution of validation documentation (URS, FRS, IQ/OQ/PQ).
• Ensure systems comply with GxP, 21 CFR Part 11, and other relevant regulations.
• Develop and update training materials for end-users.
• Conduct training sessions and onboarding for new users.
• Support internal and client-facing projects related to PV-MI technology systems.
• Collaborate with cross-functional teams to implement new features or upgrades.
• Analyse complex business needs presented by clients and the internal community and recommend & implement solutions.
• Should be able to face internal and external audits and/or inspections
• Support database migration tasks

.Qualification requirement

• Bachelor s degree in Life Sciences, Computer Science, or related field.
• Should have 2+ years of experience in Safety Database administration and/or handling of PV/Medical information enquiries.
• Familiarity with Pharmacovigilance workflows and regulatory requirements.
• Experience with validation documentation and GxP compliance.
• Excellent communication and interpersonal abilities.

Preferred Skills:

• Experience with Medical Information/Safety systems.
• Knowledge of cloud-hosted PV systems and SaaS platforms.
• Detail-oriented with strong organizational skills.
• Proactive and self-motivated with a problem-solving mindset.
• Ability to work independently and in a team environment.