Randstad Business Analyst at Biotech/Pharma in Cambridge, Massachusetts

Business Analyst at Biotech/Pharma

job details:

  • location:Cambridge, MA

  • salary:$85 - $93 per hour

  • date posted:Wednesday, October 3, 2018

  • experience:Experienced

  • job type:Temporary

  • industry:Other Services (Except Public Administration)

  • reference:S_690978

  • questions:lauri.marsanne@randstadusa.com475/549-8806

job description

Business Analyst at Biotech/Pharma

Business Analyst at Global Biotech/Pharma Cambridge, MA

Contract: 6 months with possible extension


? Drive PV business requirements in collaboration with IT, PV, Regulatory, other stakeholders for application configuration requirements, designs and debugging for new products, new licenses , studies, reporting rules, E2B profiles , code list changes in console, enhancements, MedDRA up versioning , system upgrades, workflow functionality, and validations

? Oversee user acceptance testing for PV Systems projects and activities

? Lead complex Global system and data investigations, supporting end-user inquiry and/or Global Pharmacovigilance requirements

Working hours: 8:30 AM - 5:30 PM



--Expert knowledge of database programming languages, concepts, and query tools, including Oracle SQL, PL/SQL, SAS.

--Strong understanding of Software Development Life Cycle (SDLC), including requirements gathering, technical design, and unit to system and user acceptance testing

--Experience with Computer Systems Validation, including understanding of 21 CFR Part 11, GxP compliance and validation in a regulated environment

--Process oriented focus


? General knowledge of drug development process, including excellent knowledge of Pharmacovigilance regulations and guidance as applies to regulated PV computer systems

? Excellent analytical skills

? Excellent written and verbal communication skills

? Excellent organizational and time management skills

? Working knowledge of MedDRA

? Ability to establish sound working relationships with people globally, in various functions with a wide variety of disciplines and backgrounds

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.