Project Role : Business Analyst
Project Role Description : Analyze an organization and design its processes and systems, assessing the business model and its integration with technology. Assess current state, identify customer requirements, and define the future state and/or business solution. Research, gather and synthesize information.
Must have skills : Business Requirements Analysis
Good to have skills : Life Sciences Industry
Minimum
5 year(s) of experience is required
Educational Qualification : 15 years full time education
Summary:
Business Analyst (Patient Safety / Pharmacovigilance)
We are seeking an experienced Business Analyst with a strong background in Life Sciences Patient Safety / Pharmacovigilance, supporting areas such as ICSR management, Signal Management, and Aggregate Reporting. The role is responsible for managing system requirements, change requests, and enhancements across safety platforms and ensuring seamless delivery of business and regulatory driven changes.
The ideal candidate will have 5+ years of experience in Life Sciences Safety, strong hands on experience working with safety data, and proficiency in SQL for data querying and analysis. Experience working with R&D IT systems and integrations, along with strong coordination skills across application, integration, and support teams, is essential. Proficiency in Jira and ServiceNow is required.
Roles & Responsibilities:
- Lead end to end requirements management for Pharmacovigilance systems, including enhancements, defect fixes, and change requests
- Translate safety and regulatory business needs into clear functional and data requirements
- Work with application integration and support teams to coordinate design, development, testing, and delivery of system changes
- Perform data analysis and validation using SQL to support safety use cases and impact assessments
- Support changes impacting ICSR processing, signal detection, aggregate reports, and safety analytics
- Track and manage changes, enhancements, and releases using Jira and ServiceNow
- Ensure solutions align with global PV regulations, GxP expectations, and validated system environments
Professional & Technical Skills:
- Must Have Skills: Proficiency in Business Requirements Analysis.
- Good To Have Skills: Pharmacovigilance & Drug Safety Surveillance, Veeva Vault, Life Sciences Industry.
- Strong analytical skills to evaluate complex business processes and identify areas for enhancement.
- Experience in gathering, documenting, and validating business requirements from diverse stakeholders.
- Ability to translate business needs into clear and actionable specifications for technical teams.
- Familiarity with process modeling and workflow design to support solution development.
Additional Information:
- Minimum 5 years of experience in Life Sciences, with a focus on Patient Safety / Pharmacovigilance
- Hands on experience with ICSRs, Signal Management, Aggregate Reporting, or related safety processes
- Strong proficiency in SQL and working with safety data sets
- Experience with R&D IT systems, integrations, and data flows
- Proficiency in change and delivery management tools (Jira, ServiceNow)
- Strong stakeholder management, analytical, and communication skills
- A 15 years full time education is required.
