The Safety Veeva Vault administrator will work as part of the Drug Safety Department reporting to the Senior Drug Safety Manager and will be responsible for Veeva Vault safety database administration activities and for providing technical expertise on pharmacovigilance systems, specifically the Veeva Vault database, including planning and validation. The role is critical to drug safety and pharmacovigilance to support and maintain the overall adverse event reporting system, electronic reporting to health authorities and ensuring compliance to the relevant regulatory requirements, policies and standards.
- Serves as subject matter expert for pharmacovigilance systems (Veeva Vault) and associated application integrations
- Proactively identifies safety database requirements to maximize efficiency and quality of end user performance; takes initiative to investigate, develop and implement solutions. Proactively presents solutions to management.
- Leads safety database and associated systems upgrades/patches including project planning, testing and implementation.
- Manage and escalate system issues with the pharmacovigilance software vendors as needed.
- Author, review and/or execute Validation test scripts in the implementation and testing of change controls.
- Lead project kick-off for client creation, validation and configuration. Gather functional and technical requirements. Provide configuration solutions to support client case processing and reporting. Complete documentation per Clients specifications, including, but not limited to: Business Process Mapping, Business Requirements, Functional Requirements (i.e. Technical Specifications), Test Cases, User Guides, and Administrator Guides. Lead client data migration/transfers (data imports and exports) as required.
- Complete system testing as requested, including, but not limited to: Unit Testing (in sandbox) and Smoke Testing (in production) in both browsers of Veeva CRM.
- Lead client audits and regulatory inspections.
- Lead development, validation and implementation of standard and custom reports within company reporting tools. Query database to support inspections as required.
- Builds departmental personnel knowledge of the safety database through individual mentoring, online trainings, and user workshops as needed
- Authors pharmacovigilance system work instructions, standard operating procedures and associated forms. Ensure compliance with relevant company policies and procedures.
- Bachelor's degree in Computer Science or related discipline.
- 2+ years' experience as a Veeva Administrator in a CRO or Biotechnology/Pharmaceutical environment.
- Certified in Veeva CRM administrator is preferred.
- Experience with change management, validation rules, page layouts, Apex, point and click config vs coding, QA/QC.
- Private Health Coverage
- Corporate Pension Plan
- Life Insurance
- Global General Liability Insurance
- Global Travel Insurance
- Home-based Allowance
- Internet reimbursement
- Flexible working schedule