Ref 00004821
Salary £40 – 55k
Our client is seeking a person with expert skills in Pharmacovigilance Database Systems including ideally Argus. In this permanent role you will use your understanding of drug safety data management and regulatory reporting, you leadership skills and use of Structured Query Language (SQL) to drive forward projects on a global basis.
Duties:
Assist with maintenance, change requests, documentation, system security reporting rules, configuration and data migration for the safety database systems.
Utilize system experience to mentor and train other PV operation team members as appropriate.
Assist with submission of expedited reports to Regulatory Authorities globally both electronically and in paper.
Assist in user training and maintenance of a Global Safety System User Guide for users requiring access and use of the SGSS hire to ensure efficiency, accuracy and consistency of entry and retrieval of data for investigational compounds and marketed products.
Contribute to the production and/or maintenance and training of Pharmacovigilance-specific SOPS, WPDs and Guidelines referring to the use of Global Safety Systems.
Contribute to the validation, implementation and maintenance of IT computer systems to maximize the effective use of the SGSS.
Assist Pharmacovigilance functional teams with reporting and data mining activities of the SGSS including compilation of metrics data, the use of Advanced Conditions, setting up of standard queries and reporting tools.
Lead in identifying, collating, and responding to issues raised concerning the Global Safety System(s).
Proactively work with IS staff to identify area where company would benefit new systems, system enhancements, etc. Participate in the assessment and evaluation of new software systems as appropriate.
Essential Qualifications:
Science degree and/or advanced business degree or equivalent experience.
Experience within the pharmaceutical industry. Pharmacovigilance experience strongly preferred.
Previous safety database experience, Argus preferred.
Working knowledge of Structured Query Language (SQL).
Safety database maintenance experience including configuration, custom procedures and reporting.
Advanced knowledge of Microsoft Office Suite (Word, Excel and PowerPoint).
Project management skills.
Desirable:
People management experience.
Business system design/system implementation experience helpful.
Interested? Call Avril or Michela at CSL Recruitment to confidentially discuss the next steps on +44 (0) 1932 228 928
