[Hiring] Business Analyst - Pharmacovigilance @IntelliPro Group

Role Description

The Principal IT Business Analyst role will be 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 PV IT team, the Principal IT Business Analyst will be responsible for gathering use cases and requirements to shape the initial concepts and projects. The individual will engage business stakeholders to ensure that the business needs are correctly captured and translated into IT solutions. This role 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. The Principal IT Business Analyst will also be responsible for deliverables per the system development life cycle such as business requirements, functional requirements, traceability matrices, etc. This position will report into the Associate Director of PV IT.

What You’ll Do:

• Translate conceptual user requirements into functional requirements in a clear manner that is comprehensible to developers and the project team.
• Communicate to project stakeholders, users, project managers and other project members throughout the project lifecycle changes and system enhancements to ensure that the business requirements, issues and solutions are understood.
• Collaborate with project stakeholders to determine project vision and scope, work with project team to prioritize collected requirements.
• Conduct interviews to gather user requirements via workshops, questionnaires, surveys, site visits, workflow storyboards, use cases, scenarios, and other methods.
• 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.

Qualifications

• Undergraduate degree or the equivalent combination of education and experience required.
• CBAP or PMP certification is a plus.
• 5 – 7 years of experience in business process analysis in pharmaceutical environment focused on development sciences domain.
• Experience including regulatory affairs, submission sciences, regulatory operations or preclinical safety is a plus.
• Business Process Improvement and Deviation/CAPA management.
• Well-developed business partnering & collaboration skills, including Business Process Improvement.
• Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner.
• Requirements Definition and Management.
• User Experience Design & Analysis.
• User Acceptance Testing (UAT).
• Experience of pharmacovigilance solutions in life sciences companies and knowledge of regulatory guidance and compliance (GxP and 21 CFR Part 11 regulations).
• Experience with data migration.
• Direct experience with systems such as Veeva Vault. Nice to have: Veeva Vault Safety.
• Familiarity with system application architecture.

Benefits

• The pay rate is $69/hr. on W2.
• Comprehensive benefits package, all subject to eligibility.