Product Vigilance Assistant

PE Global
04 Oct 2017
02 Nov 2017
Contract Type
Full Time

PEGlobal are looking for a Product Vigilance Assistant for their multinational pharmaceutical client based in the Berkshire area on an initial 12 month contract.

Position Summary

To assist in case processing activities involving medicines, medical devices and cosmetics as required according to timelines stipulated by corporate Standard Operating Procedures (SOPs).

Main Responsibilities of the role:

  • To receive and triage product vigilance (PV) cases from various sources.
  • To accurately record PV information on the companies Adverse Event Tracking Safety database (UKAET) and to ensure all relevant fields are completed correctly.
  • To assist in maintaining PV report case files and to ensure cases are closed according to relevant procedures.
  • To assist in administration of appropriate follow-up communications with consumers and healthcare professionals.
  • To understand and comply with local UK SOPs and WIs, and Global SOPs covering processing and reporting of AEs.
  • To verify and monitor daily and/or monthly reports from various sources including Medical Information Department (outsourcing company) and Consumer Support Team to ensure all cases have been received and processed.
  • Assist in the quality check of Social Media Listening activities.
  • To assist in the PV review of market research questionnaires.
  • Other Product Vigilance related tasks to support the PV team.
  • Support CSTL and PVTL in responding to ad hoc requests as required 100

Desired Skillset and Experience of the successful candidate

  • Ability to build and establish strong and productive relationships
  • Demonstrates exceptional attention to detail
  • Excellent written and verbal communication skills
  • Ability to prioritise work effectively
  • Demonstrates ability to work with teams and individuals
  • Good presentation skills
  • Proven expertise and experience in pharmaceutical regulations and processes is desirable
  • Degree in Pharmacy or a Life Science ideal

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