Computer Systems Validation Operations:
Monitor and Implement projects related to Drug Safety, Regulatory affairs & Branded portfolio
Provide tactical direction and guidance for changes to regulated computer systems and infrastructure
Review and Approve validation deliverables and system changes as defined in procedures as Technical Owner/Oversee and manage the project implementation activities
Acting as IT Program Manager for the Pharmacovigilance and Regulatory Affairs programs
Ensuring the continuous maintenance of GxP Applications to keep them in validated state via Change control process
Responsible for Vendor Evaluation, Budget Assessment, Budget Business Case, Vendor Shortlisting, RFP, RFI, SOWs
Ensuring continuous end user support on drug safety and regulatory affairs applications and processes,
Manage and lead regulatory audit response from IT perspective Liaising with internal and external teams/stakeholders and driving the projects to completion
Vendor/CRO Oversight Process Design/Execution