Pharmacovigilance Specialist - W.London

  • Job Reference: CR-4567-PV
  • Date Posted: 23 August 2019
  • Recruiter: gel Resourcing Ltd
  • Location: Reading
  • Salary: On Application
  • Bonus/Benefits: Competitive
  • Sector: Pharmaceutical
  • Job Type: Contract, Permanent
  • Work Hours: Full Time
  • Contact: Chris Rose
  • Email: crose@gelresourcing.co.uk
  • Telephone: 01323 332355

Job Description

Pharmacovigilance Specialist - W.London
 
Our leading client is looking for Pharmacovigilance Specialist to join their expanding company.
This is a full-time and office-based role.

They are looking for both a Contract and a Permanent candidate.

 
Role Description 

The Pharmacovigilance Specialist will be responsible for the day-to-day management of all pharmacovigilance activities, ensuring compliance with PV processes/regulations, corporate policies/procedures and monitoring of adverse events. The Pharmacovigilance Specialist will report to the Pharmacovigilance Lead. 

Responsibilities of the Pharmacovigilance Specialist:
  • Day-to-day adverse experience case management including case intake and follow-up activities, the review of local and health authority submissions of cases
  • Responsible for aggregate safety report submissions
  • Reconciliation of adverse events reports received from other internal company operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable
  • File, store and archive safety-related data
  • Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection
  • Assist in the delivery of training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors/vendors/business partners
Essential Criteria:
  • Bachelor’s Degree (or equivalent) in a Life Science, Medical Science or relevant discipline
  • Previous experience working within the pharmaceutical/clinical research industry
  • Sound understanding of pharmacovigilance regulations in the UK
  • Strong project management skills with the ability to prioritize assignments/manage time
  • Good Documentation Practices and awareness of Good Clinical Practice concepts
  • Compliance mindset/focused, high level of accuracy and quality in work
  • Familiarity with the use of a safety databases and demonstrated ability to learn new computer interface systems
  • Strong collaboration skills with the ability to work across different departments
  • Proven ability to work independently with minimal supervision
  • Excellent communication skills both verbally and in writing