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PV System Associate - Pharmacovigilance Systems Support

  • Job reference: 51395
  • Location: Maidenhead
  • Job type: Contract
  • Start date: Not specified
  • Contact: Not specified
  • Sector: Other
  • Salary: £0 per annum + negotiable dependent on skills and experience

Role: PV System Associate - Pharmacovigilance Systems Support - Inside IR35

Duration: 6 months

Location: Maidenhead

Start Date: ASAP

Rates: negotiable dependent on skills and experience

Our Maidenhead based client is currently looking for PV System Associate to join them as part of the ongoing expansion of their PVRM group. The successful candidate will be expected to provide technical support to various activities, support various internal business teams within PVRM and external teams as well as managing support activities to external vendors on a day to day basis. The position operates as a global role and is responsible for the management and oversight of system activities performed internally and externally. These are done in accordance with internal standards and conventions and external regulatory requirements across the whole organisation. You will be the point of contact for all system incidents / enhancements which are reported by global users and be responsible for quality, consistency and timely resolution of Incidents / Bugs / Change Controls and Project work.

Key Responsibilities:

  • Support and manage PV Systems - Argus and PVQ
  • Ensure PV Systems are set up to support PVRM requirements of Quality ICSR while meeting regulatory requirements
  • Ensure submissions are made on time by resolving incidents in a timely fashion.
  • Establish, develop and implement standard operating procedures, guidelines and standards.
  • Ensure Incidents are resolved in time, are cost effective and have high quality.
  • Define and establish relevant roles and responsibilities for working with vendors and identify potential risks associated with the relationship.
  • Establish and implement Oversight and KPIs for Vendor.
  • Facilitate prioritization, resolution of any issues, measure and monitor the quality of work
  • Ensure vendor is trained and compliant with all relevant standard operating procedures

Experience Required:

  • Experience with any Safety Systems ARISg or Oracle Argus or any bespoke Safety systems.
  • Experience with any reporting tools like Business Objects or IBM Cognos or Tableau etc.
  • Experience with GxP systems validation and documentation.
  • Experience in using SQL and TOAD.
  • Bachelors/Master's in Computer Science or Masters in Computer applications or any other equivalent Computer science/degree
  • Pharma systems experience, specifically Pharmacovigilance experience, or an equivalent setting
  • In depth knowledge of global and local regulations governing drug safety
  • Global Pharmacovigilance database knowledge

This role will require some travel.

If this sounds of interest and you require further information then please respond with an up to date copy of your CV.

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