Qode

Business Analyst

  • Qode

Job Description

Job Summary
We are seeking an experienced Business Analyst with strong domain expertise in Pharma or Life Sciences to bridge business needs and technical solutions. The ideal candidate will work closely with stakeholders, product owners, and technology teams to deliver data-driven, compliant, and scalable solutions supporting clinical, regulatory, commercial, or manufacturing functions.

Key Responsibilities
·      Gather, analyze, and document business requirements from pharma/life science stakeholders
·      Translate business requirements into functional specifications, user stories, and process flows
·      Collaborate with cross-functional teams, including IT, data, QA, and regulatory teams
·      Support initiatives across Clinical, Regulatory Affairs, Pharmacovigilance, Manufacturing, or Commercial domains
·      Ensure compliance with industry regulations (GxP, FDA, EMA, HIPAA as applicable)
·      Perform gap analysis, impact analysis, and solution validation
·      Assist in UAT planning, execution, and defect management
·      Create and maintain documentation such as BRDs, FRDs, SOPs, and traceability matrices
·      Support data analysis, reporting, and dashboard requirements where applicable.

Required Skills & Qualifications
·      Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field
·      10+ years of experience as a Business Analyst in Pharma or Life Sciences
·      Strong understanding of pharma business processes and terminology
·      Experience with SDLC, Agile/Scrum, or SAFe methodologies
·      Excellent stakeholder management and communication skills
·      Strong analytical and problem-solving abilities.

Preferred Skills
·      Experience with clinical systems (CTMS, EDC, eTMF), safety systems, or commercial analytics
·      Knowledge of data platforms, BI tools (Power BI, Tableau), or SQL
·      Experience working in regulated environments (GxP validation)
·      Certifications such as CBAP, PMI-PBA, or Agile BA