Business Analyst - Pharmacovigilance at IntelliPro Group Inc.

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Sep, 26

Salary

69.0

Posted On

13 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Business Process Analysis, Requirements Gathering, User Acceptance Testing (UAT), Pharmacovigilance, Veeva Vault, Data Migration, GxP Compliance, 21 CFR Part 11, Functional Specifications, User Experience Design, CAPA Management, SDLC, Stakeholder Management, Traceability Matrices, Business Process Improvement, Regulatory Affairs

Industry

Staffing and Recruiting

Description

Job Title: Business Analyst (Pharmacovigilance) – Remote Duration: 06 months with possible extension Pay rate: $69/hr. on W2 About this role: 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 role 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 Who You Are: You are an IT professional experienced in business process analysis in a life sciences environment. You possess excellent communication skills, and ability to make decisions in a rapid paced, dynamic environment. You are comfortable working with both IT and business stakeholders at all levels. Education & Required Skill: 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. Having 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. About Us: Founded in 2009, IntelliPro is a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. We continue leading global talent solutions with a dynamic presence in over 160 countries, including the USA, China, Canada, Singapore, Japan, Philippines, UK, India, Netherlands, and the EU. IntelliPro, a global leader connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, IntelliPro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants. Learn more about our commitment to diversity and inclusivity at https://intelliprogroup.com/. Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more. Additionally, IntelliPro provides a comprehensive benefits package, all subject to eligibility.

Responsibilities

The role involves eliciting and documenting functional and business requirements to deliver IT solutions for the Pharmacovigilance team. The analyst will translate user needs into technical specifications and collaborate with stakeholders to define project scope and dataflows.