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Principal Business Analyst- Pharmacovigilance
Principal Business Analyst- Pharmacovigilance-March 2024
Cambridge
Mar 16, 2025
ABOUT BIOGEN
Biogen is on a mission to transform patient lives by pioneering and leading in neuroscience.
5,001 - 10,000 employees
Biotechnology, Healthcare
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About Principal Business Analyst- Pharmacovigilance

  Job Description The Business Analyst role is to fully understand the information and automation needs of the stakeholder community with whom they work.  This understanding is the basis for their essential work which is to elicit, analyze, validate, specify, and document the functional and business needs of stakeholders in the context of delivering IT services and solutions. 

  As a key role in Pharmacovigilance IT team, the Business Analyst role will be responsible for gathering use cases and requirements to shape the initial concepts and projects. They will engage business stakeholders to ensure that the business needs are correctly captured and translated into IT solutions. They will outline business processes, define the dataflow, analyze options among existing and new tools, and facilitate prioritization and simplification in providing the feasible solutions to achieve short- and long-term business goals. They will also be responsible for deliverables per the system development life cycle such as business requirements, functional requirements, traceability matrices, etc.

  Key Responsibilities

  Translate conceptual user requirements into functional requirements in a clear manner that is comprehensible to developers and the project team.Communicate to project managers, business partners, and other stakeholders throughout the project lifecycle and be the champion to ensure/communicate system changes/requirements are prioritized and met.  Identify gaps and inefficiencies in business processes and coordinate with business users in developing to-be processes from as-is processes.Act as a single point of contact for, business users, Project Managers, and the development teams for all the communication throughout the project lifecycle.Coordinating with project managers to help enforce Systems Development Life Cycle standards and required regulations to projects.To have a unified global view, aligned with Global IT Strategy, ensuring the provision of architecturally aligned, well integrated business solutions. Work closely with the development teams to discuss enhancements, system requirements and feedbacks on new releases. Ensuring the enhancements made is appropriate and acceptable to the end users.Collaborate with IT/business owners to determine project vision and scope.Conduct interviews to gather user requirements via workshops, questionnaires, surveys, site visits, workflow storyboards, use cases, scenarios, and other methods.Work with stakeholders and project team to prioritize collected requirements.Develop necessary documents, e.g., statement of work, project objectives & metrics, business requirements, use cases, storyboards, functional specifications, systems & end-user documentation.Conduct or support trainings for application users and IT application support team. Preferred Skills

  Enterprise ArchitectureSolution PlanningStakeholder Relationship ManagementDesign ThinkingData Analysis  Education

  Bachelor's degree. Master’s degree as a plus.CBAP/ ECBA / CCBA / CBAP certification preferred.  

  Qualifications Required Skills:

  7 Years of Business/Process analysis experience in pharmaceutical environment focused on development sciences domain, including 4+ years of Pharmacovigilance experience.Strong analytical skills required, including a thorough understanding of how to interpret business needs and translate them into application and operational requirements.Proven ability to drive complex conceptual discussions and develop system requirements. This includes the ability to generate innovative ideas to resolve problems.Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of executives, managers, and subject matter experts.Work with minimal guidance; seek guidance on complex tasks.Ability to handle multiple projects (including a mix of small to complex) at any given time, set priorities, schedule, and meet deadlines.Experience of IT solutions in Pharmacovigilance, including areas like case processing, signal detection in life sciences companies and knowledge of regulatory guidance and compliance (GxP and 21 CFR Part 11 regulations).Demand management and supporting User Acceptance Testing (UAT) Preferred Skills

  Enterprise ArchitectureSolution PlanningStakeholder Relationship ManagementDesign ThinkingData Analysis  Education

  Bachelor's degree. Master’s degree as a plus.CBAP/ ECBA / CCBA / CBAP certification preferred. Additional Information

  Why Biogen?

  Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

  At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

  All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

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