Business Systems Analyst

Business Systems Analyst

Mandatory Skills: Patient Safety (Pharmacovigilance) and Medical Affairs domains JD: Specific Responsibilities and Skills: Proactively seeks out opportunities, actively monitors and identifies capability gaps and proposes potential solutions through research internally and externally. Act as a thought leader in Patient Safety (Pharmacovigilance) and Medical Affairs domains ensuring the team continues to innovate and delivers business value & efficiency.Act as a thought leader in Patient Safety (Pharmacovigilance) and Medical Affairs domains ensuring the team continues to innovate and delivers business value & efficiency. Document process workflows and frameworks to facilitate discussions with business stakeholders. Participates in requirements discussions and design review of systems. Prepare business requirement documents (BRD). Develops business cases for new projects & initiatives to support business strategy. Business cases are developed with clear objective, business value justification and return on investment metrics. Ensures timely project approval submissions occur following both quarterly and annual cycles by working with IT project management office. Assists in identification of project deliverables, project time estimations and resource level estimations. Prepares financial estimates by working the cross functional IT and business teams. Responsible for keeping capabilities maps associated with relevant technologies up to date for Patient Safety (Pharmacovigilance) and Medical AffairsAffairs. Participates in the Request for Approval (RFP), reviews statement of work and license agreements. Manages strategic relationships with product vendors, holds periodic review sessions to ensure Gilead business needs are prioritized. Ensures clear communication occurs among cross functional teams, sets clear expectations, and serves as an escalation account manager for the business. Partners with Validation and QA teams to ensuring GxP assessments and Validation scope for projects are well understood. Knowledge, Experience and Skills: Must have demonstrated system implementation and management experience of Pharmacovigilance and Medical Affairs systems areas in a Bio-pharmaceutical industry. Laser-focused and strong delivery experience managing large, complex projects. Must think ahead strategically and must be able to weigh and decide between implementing new functionality by configuration of existing technology vs assessment of new technology. Has a strong working understanding of installed systems, is aware of integration and data flow points with other enterprise systems. Demonstrates proficiency with one or more technology environments, with the ability to learn and apply new and emerging concepts very quickly. Excellent interpersonal, communication, and business partnering skills Strategic mindset with strong analytical foundation Ability to analyze complex business problems and evaluate solutions Ability to translate complex technical issues into business terms. Good understanding of GxP compliance and 21 CFR Part 11 requirements.