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Senior Associate: PV Systems

  1. South East
South East England
  1. Contract
Competitive
  1. Drug Safety / Pharmacovigilance
21-04-2020
24578/LH

This vacancy has now expired

Senior Associate: PV Systems - Global Pharmaceutical Client – 6 Month Contract in the South East

Our client, a leading global pharmaceutical company and leading vaccines giant, are seeking a senior pharmacovigilance systems associate, to join their team on a 6-month contract basis. Initially home-based, this role offers the opportunity to play vital role on a project with a unique singular global focus.

Essential Duties and Responsibilities include:
  • Support and manage PV Systems – Argus and PVQ (COGNOS based application)
  • 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 for Seqirus for PV Systems
  • Ensure Incidents are resolved in time, are cost effective and have high quality
  • Ensure changes are resolved in time, are cost effective and have high quality. Communication must be done to all impacted stakeholders
  • 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 company- standard operating procedures

Requirements:
  • 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
  • To be able to easily converse technical details in simple terms with the Business teams
  • Strong communicator with excellent English language skills, both written and spoken
  • Self-motivated, able to prioritise and plan effectively with a high sense of responsibility and accountability
  • Ability to work independently and as a team player in a cross-functional environment
 
If you are interested in this role, please apply today for more information!



The candidate must have the rights to work in the location stated in the job advert.

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