Pharmacovigilance Associate

The ideal candidatw will have previous expereince working as a Pharmacovigilance Associate, and be a professional person whom will be able to hit the ground running with minimal supervision.

RESPONSIBILITIES
1 To receive spontaneous cases from the Medical Information department or any other relevant source.
2 To accurately record AE information on the UK Adverse Event Tracking system and to ensure all relevant fields are completed correctly.
3 To maintain Adverse Event report case files.
4 To manage administration of appropriate follow-up communications with consumers and healthcare professionals.
5 To understand and comply with local UK SOPs and WIs, and GMS SOPs covering processing and reporting of AE's.
6 Responding to queries from the Medicines and Healthcare products Regulatory Agency (MHRA), Irish Medicines Board (IMB) and/or Maltese Authority in a timely manner.
7 Assessing Anonymised Single Patient Reports (ASPR) received via the MHRA Sentinel portal and reporting to GMS within agreed timelines.

It is important that they can demonstrate strong experience in Adverse Event case processing and the candidate must be familiar with Volume 9A Guidelines. There is a fair amount of admin associated with the role so candidates will also need to demonstrate excellent organisational skills.

If you are interested in this role please contact Jessica Warden-Brown on the contact details below.

To find out more about Real Staffing please visit www.realstaffing.com