Job Description
Role Purpose
The purpose of the role is to create exceptional product architectural design for the existing and new products and enable delivery teams to provide exceptional client engagement and satisfaction.
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Role Overview
We are seeking a proactive and experienced Lead Business Analyst to join our pharmacovigilance literature monitoring platform team. The ideal candidate will lead requirement gathering, documentation, and stakeholder engagement across multiple pharmacovigilance workflows, ensuring delivery excellence and team alignment.
Key Responsibilities:
Business Analysis & Documentation
Lead the creation of BRDs, FRDs, RTMs, and change request documents.
Ensure requirement traceability and completeness across the lifecycle.
Validate deliverables against business expectations and manage UAT cycles.
Stakeholder Engagement:
Interface with client stakeholders, development teams, and QA to clarify requirements and resolve blockers.
Conduct walkthroughs and demos for requirement sign-offs.
Address escalations and feedback from business and operations teams.
Team Leadership & Collaboration:
Mentor junior analysts and coordinate with peers to ensure consistency in delivery.
Align with PMs and support managers on resource planning and allocation.
Foster a collaborative environment and resolve interpersonal challenges constructively.
Technical & Functional Oversight:
Participate in feasibility discussions and deployment planning for CRs.
Governance & Compliance:
Support internal audits and validation summary reporting.
Ensure documentation readiness for compliance-heavy workflows (e.g., ICSR/NICSR, multi-patient cases).
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Required Skills & Experience:
Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences or a related field.
8–12 years of experience in business analysis, with at least 3 years in a lead role.
Strong domain knowledge in pharmacovigilance, publishing, or life sciences.
Hands-on experience with XML, SFTP, and structured reporting.
Experience with SQL and relational databases for data analysis.
CSV & GxP documentation knowledge (URS, FRS, validation, audit trails).
Familiarity with clinical systems (EDC, eSource, CTMS, eTMF, Regulatory Compliance).
Strong communication and stakeholder management skills to lead requirement discussions, demos, and collaboration efforts.
Project coordination experience, including timeline management and risk identification.
Ability to work independently and as part of a team.
Experience in principles of Change Management.
Preferred Qualifications:
Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences or a related field.
Experience working with international clients and regulatory environments.
Familiarity with other prominent pharmacovigilance platforms.
Additional Notes:
The role will interface regularly with senior stakeholders and should be comfortable with executive level collaborations.
Candidate must be comfortable working in a fast-paced, multi-stakeholder environment with high visibility deliverables.