Work Schedule
Environmental Conditions
Job Description
Provides technical leadership and guides the Pharmacovigilance business to refine and automate business processes and establish system needs. Gathers, analyzes and documents user requirements for various business initiatives. Liaisons with IT and ensures requirements are appropriately translated into design specifications for systems and reports. Analyzes systems support issues and enhancements requests and identifies workarounds or works with IT to design solutions.
Major Job Responsibilities:
- Managed access configurations across Argus suites, including Admin and Axway .
- Handling Argus upgrade initiatives and data migration projects.
- Configured Product/Codelist, Product Family, and Study/License/Product setups, while thoroughly documenting planned
and routine changes to ensure alignment with end-user requirements.
- Solicits and documents requirements for various project initiatives, analyzes those requirements, works with IT and ensures that requirements are properly translated into design specification for systems and/or reports.
- Works independently and defines, streamlines and automates business processes. Provides support in relevant SOP/WPD development.
- Solves complex support issues and analyzes root cause for enhancement opportunity, and identifies workarounds or works with IT to design solutions.
- Liaises with the business and IT and ensures that all the components and services required for various project initiatives are properly delivered in a timely manner.
- Trains end users for systems and processes. Mentors, guides and trains Safety Systems Analysts and Safety Systems Administrators. May serve in a lead capacity.
- Attends client meetings when needed and supports the development of proposals for new business.
- Stays abreast of the latest developments in related technologies; Shares knowledge with team members. Performs other duties as assigned.
Education / Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
Knowledge, Skills and Abilities Required:
- In depth knowledge of Pharmacovigilance processes including applicable SOPs, ICH GCP, current pharmacovigilance regulations and local guidelines
- Knowledge of document management concepts and systems, and workflow/process automation concepts and tools
- Advanced technical & business understanding of safety and clinical systems
- Client-focused approach with strong interpersonal skills
- Strong written and verbal communication skills
- Robust problem solving and analytical skills
- Strong planning