01Responsibilities
Configure, maintain and manage the Safety Database with high data quality and accuracy.
Administer user roles, permissions, and access controls in compliance with data privacy and regulatory requirements.
Coordinate and implement system upgrades, patches, and hotfixes in collaboration with IT and vendor teams.
Manage integration of safety databases with other systems such as E2B (R2/R3) gateways, signal detection tools, or document management systems.
Support periodic system validation, including authoring/review of validation documents (URS, FRS, IQ/OQ/PQ).
Ensure compliance with global regulatory requirements (e.g., EMA, FDA, PMDA) and standards such as 21 CFR Part 11 and EU Annex 11.
Provide end-user training and system support to case processors, medical reviewers, and QA personnel.
Participate in safety database migrations and data reconciliation projects during system transitions or audits.
Requirements
Job Description:
Maintain documentation and audit trails, and support internal/external audits and regulatory inspections.
Generate metrics and compliance dashboards related to case processing time .
