Business Analyst (Pharmacovigilance, REMS)

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Job description

Title: Business Analyst

Location: Berkley Heights, NJ 07922

Duration: 9 Months (possible extension)

Note: The candidate must be able to work onsite once the WFH policy is lifted, so local is preferred. Those not local will be considered if they are willing to relocate at their own expense. Vaccination is mandatory

Must Haves:

• 7+ years of experience in business/business systems analysis
• 7+ years of experience in developing User Acceptance Test Plans, Test Scripts, Summaries, and perform test execution
• 2+ years of experience in Risk Evaluation Mitigation Strategies (REMS)
• 2+ years of experience of working with a regulated system/environment
• 2+ years of Pharmacovigilance experience

As part of the IT Business Partnership Team, the Business Analyst supports the Global Risk Management Team. The Global Risk Management team is a fast-paced collaborative, diverse, and complex environment. The ideal candidate must be a self-motivated, and detail-oriented professional.

The business analyst must have:

• Minimum of 7 years of experience in business/business systems analysis
• Minimum of 2 years of experience in Risk Evaluation Mitigation Strategies (REMS)
• Experience working with a regulated system/environment
• Ability to multi-task diverse activities
• Well-developed oral and written communication skills
• Strong organization and planning skills
• Logical decision making using analytical and problem-solving skills
• Ability to collaborate with the business as well as technical areas
• Flexibility in working hours to accommodate international calls and deliverable deadlines
• Ability to travel internationally
• Pharma experience is a plus+

Scope of Work

• Support projects and initiatives within the Global Risk Management business area
• Elicit and create requirements specifications as requested by business and technical areas (Business Requirements, User Requirements, and Functional Specifications)
• Ensure that various appropriate SDLC documents are kept up to date and are available
• Create and develop user requirements and/or functional requirements of systems to improve quality, performances, external interfaces, and constraints
• Carryout analysis of requirements by checking for derived requirements that are logical to customers' requests
• Outline requirement specifications with the use of standard templates for both use cases and detailed software
• Manage requirements and ensure they are stored in document management systems
• Record, manipulate, and generate reports on requirements stored in the requirements management tool (such as Blueprint Requirements Center, ALM)
• Supervise requirements traceability information and record requirements status for the project
• Monitor changes to baseline requirements with applicable change control processes and tools
• Develop User Acceptance Test Plans, Test Scripts, Summaries, and perform test execution as required
• Participate in the supervision/coordination of User Acceptance test execution by business teams
• Perform relevant activities including documentation, training, and other work as directed by IT Business Partner

This is not necessarily an all-inclusive list of job-related responsibilities, duties, skills, efforts, requirements or working conditions. While this is intended to be an accurate reflection of the current job, SPECTRAFORCE and the assigned client reserve the right to revise the job or to require that other or different tasks be performed as assigned.

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at if you require a reasonable accommodation.

- provided by Dice