Business Analyst - Pharmacovigilance

Posted 2 Days Ago
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Cambridge, MA, USA
In-Office
69-69 Hourly
Senior level
HR Tech • Information Technology
The Role
Serve as Principal IT Business Analyst for Pharmacovigilance: elicit, analyze, validate and document business and functional requirements; define processes and dataflows; evaluate tools and propose solutions; produce BRDs/FRDs/traceability matrices; support UAT, data migration and user training while partnering with IT and business stakeholders.
Summary Generated by Built In
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.

Skills Required

  • Undergraduate degree or equivalent combination of education and experience
  • CBAP or PMP certification
  • 5-7 years of experience in business process analysis in a pharmaceutical environment focused on development sciences domain
  • Experience in regulatory affairs, submission sciences, regulatory operations or preclinical safety
  • Business Process Improvement and Deviation/CAPA management
  • Well-developed business partnering and collaboration skills
  • Excellent oral and written communication skills
  • Requirements definition and management
  • User Experience Design and Analysis
  • User Acceptance Testing (UAT)
  • Experience with pharmacovigilance solutions and knowledge of regulatory guidance and compliance (GxP and 21 CFR Part 11)
  • Experience with data migration
  • Direct experience with systems such as Veeva Vault
  • Experience with Veeva Vault Safety
  • Familiarity with system application architecture
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The Company
HQ: Santa Clara, CA
638 Employees
Year Founded: 2009

What We Do

IntelliPro Group Inc. is one of the fastest growing IT services and HR solutions companies in Americas & APAC. We provide comprehensive IT services to help clients with IT Strategic Planning, Implementation, Deployment, IT Support on Artificial Intelligence, Big Data, Cloud Computing, Mobile Application Development, Data Mining and Business Intelligence, Enterprise Data Warehouse, and more. Besides our established IT services, our new business now is quickly extending to one-stop HR Solution Services, including Oversea Branch Setup Consulting, Compensation & Benefits Policy Consulting, Payroll Management Service, Talent Recruiting, and Employer Branding to satisfy our clients’ fast business expansion requirement. We have built our business on our company-wide commitment to continually overdeliver on the high expectations of our clients, employees, and business partners. The secret to our success is that our unified team works harder, faster, smarter, and more collaboratively than anyone else in the talent acquisition business. In addition to the immense talent and proprietary technology, IntelliPro Group is proud to offer continual professional development and extraordinary benefits to both consultants and full-time employees.

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