Product Safety Executive - Pharmacovigilance - Pharmaceutical

Posted 17 April by Atom Recruitment Ltd.
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Our Client is a very successful pharmaceutical company. They are now seeking a Product Safety Executive to join their Pharmacovigilance team in the Regulatory and Clinical Affairs Department. This position is a full-time permanent role and will be office based in Hertfordshire.

Job Profile

  • Working within the team responsible for managing product safety (the Pharmacovigilance team), the overall job purpose is to ensure all adverse events, adverse incidents and other qualifying reports ('product safety reports’) are managed and processed in a timely manner according to current regulatory requirements and company procedures using their electronic pharmacovigilance data management system (PV247)

Key Areas of Responsibility

  • To ensure all types of customer product feedback reports (i.e. both product safety reports and product complaints involving alleged quality defects or deficiencies) are collected from all sources and reconciled centrally by the Pharmacovigilance team. This involves effective integration and cooperation with functions interfacing with Pharmacovigilance such as Telephone Receptionists / Mail Room operatives, Sales and Marketing, Clinical Research, Product Quality, Queries Handling / Medical Information, Systems, Regulatory Affairs and relevant third-party contractors
  • To ensure the secure maintenance of all records of customer product feedback - whether cases entered on the legacy Product Complaint Forms / Box files / Spreadsheets or cases entered onto the current electronic pharmacovigilance data management system
  • To manage and maintain the electronic pharmacovigilance data management system. This includes: Assisted by a third-party system developer / supplier, being the "go-to" person for user support and advice on all aspects of using the system / Assisting in ensuring the system is maintained in a validated state according to company IT requirements and appropriate change control processes / Ensuring that system-related work processes are set out in written Work Instructions and Standard Operating Procedures
  • To oversee and ensure data entry of all customer product feedback reports onto the electronic pharmacovigilance data management system
  • To triage all incoming cases, separating a) product safety reports for management by the Pharmacovigilance team (i.e. adverse events, adverse incidents and other qualifying reports) from b) product complaints of alleged quality defects or deficiencies, and handing off the latter for investigation and remedy by a separate team (QA)
  • Where applicable, to attempt retrieval of allegedly defective product and/or photographic evidence thereof, and in all cases perform all customer follow-up and conciliation in a timely manner
  • Working with other members of the Pharmacovigilance team, to use the electronic pharmacovigilance data management system to ensure the timely reporting of all relevant product safety reports to the Regulatory Authorities and relevant bodies as applicable, and to assist with product safety report investigation and remedy by escalation into safety signal trackers and safety Corrective and Preventive Actions (CAPAs) as necessary
  • To help ensure all safety records and associated documents are attributable, legible, contemporaneous, original (or a verified copy), accurate, secure and accessible
  • To help ensure the department’s and its service providers’ compliance with General Data Protection requirements
  • To assist in the generation of product-related queries and reports for safety trend analysis, signal detection, ongoing product risk and performance management, and to advise on data presentation format
  • To help perform and record weekly searches of the published scientific literature for safety information relevant to the company’s developmental and marketed products and to maintain relevant papers in a bibliographic database (EndNote). The latter also includes obtaining / ordering published papers in accordance with copyright requirements
  • To help design, implement and continually improve the pharmacovigilance function in accordance with evolving regulatory requirements and the company’s Quality Management System
  • To maintain continual professional excellence through formal and informal training initiatives
  • To supervise a Product Safety Administrator
  • To perform other duties as assigned, including mentoring and training.

Qualifications / Experience

  • A background in pharmacy, nursing or healthcare delivery would be advantageous but is not essential
  • Some regulatory knowledge of pharmacovigilance requirements for medicines and medical devices would be advantageous but is not essential
  • Meticulous attention to detail and record keeping
  • Excellent problem-solving skills
  • Well organised and process-oriented
  • Strong written and verbal communication skills, especially for interacting with customers and non-technical staff
  • Practiced and at ease with using computer data management systems

In return our client is offering a basic salary of £30,000 - £40,000 per annum plus benefits for the successful Candidate

Please send your C.V and a covering letter to Lorraine Roger, Director at Atom Recruitment Ltd.

Required skills

  • Communication Skills
  • Drug Safety
  • Pharmaceutical
  • Pharmacovigilance

Reference: 37781203

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