IT Compliance Specialist

Posted 8 Days Ago
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Utrecht, NLD
Hybrid
Mid level
Pharmaceutical
The Role
The IT Compliance Specialist will handle compliance related to IT systems, manage documentation for audits, perform risk assessments, and ensure adherence to standards and regulations.
Summary Generated by Built In
Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

This role is hybrid - Based in Utrecht, Netherlands

Job Description

In this role, you will focus on compliance matters related to in-house IT systems and processes. You will work with documents to make sure that PSI meets standards, industry requirements, and internal policies.

  • Create, update and process internal IT documents (change control, risk assessment, computer system inventory, validation, disaster recovery plan and the like)
  • Generate and provide IT documentation for internal and external audits
  • Take part in IT interviews during internal and external audits
  • Provide answers to IT questions from sponsors and during review of client and vendor agreements
  • Follow up on resolution of audit findings related to IT compliance
  • Support development and update of IT-related documents
  • Participate in the development of departmental QSDs
  • Monitor and ensure compliance with PSI QSDs, relevant laws, regulations and standards
  • Participate in regular risk assessments to identify potential vulnerabilities in IT systems and processes

Qualifications

  • College or University degree
  • Prior experience in IT and/or compliance matters
  • Meticulous, able to work with documents and processes
  • Full working proficiency in English
  • Communication skills and ability to build relationships at all levels

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.

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The Company
HQ: Zug
1,939 Employees
Year Founded: 1995

What We Do

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense'​ CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com

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