Senior Business Analyst (Pharmacovigilance)

The ideal candidate will play a role in the development of multiple parts of the business by analyzing past, current, and future business trends. This individual will establish strategies to achieve desired outcomes and implement these strategies. They will often work cross-functionally with internal business units in order to understand the challenges that these teams are face and provide solutions to these groups.

Responsibilities

• Act as a Senior Business Analyst supporting Pharmacovigilance(PV) systems and processes.
  

Work extensively on Argus Safety and other PV-related applications to support business and regulatory needs.

• Serve as a client-facing liaison, gathering, analyzing, and documenting business requirements.
  

Lead and support change management activities, including impact analysis, stakeholder communication, and implementation support.

• Prepare, update, and review functional documents such as BRDs, FRDs, SOPs, user guides, and validation documentation.
  
• Ensure compliance with GxP regulations and industry standards throughout the project lifecycle.
  

Collaborate with cross-functional teams (IT, QA, PV operations, vendors) to ensure timely and quality delivery.

• Support UAT planning and execution, defect tracking, and resolution.
  
• Participate in audits, inspections, and regulatory assessments as required.
  
• Provide guidance and mentoring to junior analysts when needed.
  

Requirements

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Computer Science, or a related field.
  
• 8+ years of experience as a Business Analyst in Pharmacovigilance or Life Sciences domain.
  
• Strong hands-on experience with Argus Safety and solid understanding of PV processes.
  
• In-depth knowledge of GxP regulations and compliance requirements.
  
• Proven experience in change management, requirement analysis, and documentation.
  
• Excellent client-facing and stakeholder management skills.
  
• Strong analytical, problem-solving, and communication skills.
  
• Experience working in regulated environments and supporting audits.
  
• Ability to work independently and manage multiple priorities effectively.