Drug Safety Consultant

We are looking for you – with a keen eye towards IT design, bringing best practice processes to the drug Safety landscape.

#drugsafety #pharmacovigilance #SafetyInternationalRegulations #Itdesign #trustedadvisor

As a Safety Application Consultant, you will be involved in the entire project life cycle from pre-sales to customer advisory, configuration and development through implementation to maintenance.

NNIT Clinical in life-science technologies:

As part of NNIT’s Clinical team, you will be working together with more than 230 experienced professionals in a global setting - from Denmark to United States, from China to the Philippines – NNIT Clinical team is responsible for advising our customers on business and technology as well as designing and implementing IT solutions and applications.

Main responsibilities:

As a Drug Safety Consultant, you are responsible for understanding customers business processes. You are knowledgeable around regulatory requirements and you can translate the customer's requirements into system configurations, covering both functional and technical aspects. It is expected that you can translate requirements into an implementation strategy by leading and concluding workshops.

As the frequency of releases of regulatory requirements are increasing, a part of your responsibility role will be to support life sciences customers in the rapid configuration and implementation requirement into Veeva Vault Safety.

With your ability to work as a consultant you can understand the customer state of an existing implementation, perform gap analyses and propose validation strategies to enable the customers to follow current and future requirements.

You are the subject matter expert in Drug Safety and Pharmacovigilance for customers and project teams. Your role will also be to bring other people on board on the Safety journey from NNIT’s global organization.

As the work is expected to be linked to the existing landscape of Drug safety application, it will be an important skill to understand applications and data models supporting the Drug Safety e.g. ARGUS and ARISg.

Your qualifications and experience

You must have several years of life sciences industry experience, with the majority spent in the Drug Safety and Pharmacovigilance domain, as well as an experience in a consulting function. Based on our profile and experience you must have an in-depth knowledge of Drug Safety and Pharmacovigilance processes and regulations. To enable the continuous best consultancy, it is needed that you possess a natural interest in the new technologies and are familiar with market leading Safety solution vendors.

It is important that you:

  • Have extensively worked on implementations, upgrades, configurations and migrations of Drug Safety Databases like ARGUS and ARISg,
  • Can act with speed to understand business requirements, create corresponding solution designs,
  • Are exposed to life sciences compliance and computer systems validation requirements,
  • Have a strong customer centric approach, can understand and effectively communicate customer requirements and needs,
  • Take pride in delivering on time and on budget while keeping the customers best interest in mind,
  • Are an ambitious team player who enjoys taking responsibility of your own assignments,
  • Have an excellent communication skills in English.

Your personality requires that you have a willingness to “roll up your sleeves” to design, configure and drive Vault Safety projects.

The abilities that will be a nice to have are:

  • Proven track record supporting high impact global system implementation programs as a consultant, business or IT lead, and/or business sponsor,
  • Direct experience with ARISg and/or other drug safety applications,
  • Life science, computer science, or related degree,
  • SaaS/Cloud experience,
  • Experience in services delivery management and/or systems implementation.

 


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