Information Analyst – Deerfield, IL
PRA Health Sciences
Do you want to watch clinical development change, or do you want to be the one to shape it?
Because we’re hoping you’re here for the latter.
Who are we?
We Are PRA.
We are 11,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.
Who are you?
You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be an Information Analyst, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
Still here? Good. Because if this is you, we’d really like to meet you.
What will you be doing?
As an Information Analyst, you will be part of the Information Management team ensures that data stored and maintained in GRA’s Regulatory Information Management (RIM) environment(s) is current, accurate, reliable and generally fit for purpose at any given point in time. The function secures the integrity of data that is used internally for business intelligence / reporting purposes and externally to comply with global Regulatory agency information requests and obligations. This function acts as the custodians of GRA’s information management landscape and will input to / align with Takeda’s global Master Data Management strategy/ies as appropriate.
The Information Analyst role is focused on delivery of one or more service lines offered by the Information Management team. Examples of such service lines are:
- Business intelligence and compliance reporting.
- Data provision and submission to external databases such as eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) and ISO Identification of Medicinal Products database (IDMP).
- Data quality management and remediation.
- Co-ordination of data entry work undertaken by Information Analysts.
- Proactively works with the GRA business to maintain and align system dictionaries / code lists to the appropriate company / industry / agency standard(s).
- As a professional in the field of Regulatory Information Management collaborates with data owners to ensure that data is entered into the company’s RIM system(s) in compliance with company / industry / agency standard(s).
- Acts as a quality gate to ensure compliance with the company’s Regulatory Information data standard is maintained at all times. Manages resolution of any resulting Quality Investigations or CAPAs with internal stakeholders / QA.
- Prepares and ensures the submission of data and supporting documentation to external agency databases (i.e. XEVMPD, ISO IDMP) in compliance with agency requirements and standards. Actively contributes to responses to agency queries raised as a result of making these submissions.
- Builds strong working relationships with information providers / verifiers (primarily) within GRA to encourage and support accurate, timely and reliable entry of Regulatory information into the company’s RIM system(s).
- Supports the RIM team in the interrogation of Regulatory Information to identify trends that can be presented in business intelligence reports to management.
- Proactively monitors relevant agency guidelines / regulations that are noticed in the course of everyday business to ensure that potential impacts / new requirements are identified and managed at the optimum time.
What do you need to have?
- First degree in Information Management, Life Sciences, Computer Science or similar; these requirements can be waived for exceptional candidates who can demonstrate substantial, relevant work experience over a sustained period (minimum 2 years).
- 1-3 years’ experience of working in a Global Regulatory Affairs function demonstrating an awareness of global Regulatory authority procedures.
- Experience of working with data in RIM systems and of performing advanced queries in such systems.
- Knowledge and Skills
- Systems / RIM Knowledge
- Some experience of using and administrating RIM systems.
- Some experience of managing Regulatory Information in controlled Regulatory Information Management systems to defined quality standards. Extensive experience of working with external data standards (pharmacopeia, standard terms, ISO, MedDRA etc).
- Regulatory Familiarity
- Some background in Global Regulatory Affairs as well as understanding of European, US and international regulations relative to RIM.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. Side-by-side with our clients, we strive to move drug…