Our client is seeking a candidate 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, your leadership skills^and use of Structured Query Language (SQL) to drive forward projects on a global basis.
This is a role where you can truly influence both company and vendor outputs, improve compliance and share knowledge across boundaries and with subordinates.Theconditions of employment are superb, relocation support is generous and this role will allow you to settle in an area of outstanding beauty well located for London, the coast and countryside.
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 consistencyof 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 ofmetrics 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.
An appointment can be made at Manager or Specialist level. Beneifts of employment are superband there is a relocation package available.
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.
Keywords:
Pharmacovigilance, Database, Systems, Argus,permanent,safety, data, regulatory, leadership,SQL, global, compliance, relocation, London, change requests, documentation, system security, configuration, data migration, safety database systems, regulatory authorities.