Senior PV Officer

£0.00 - £45000.00 per annum
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United Kingdom
Windsor, Berkshire
Posting date: 25 Apr 2019
DS.DM.22851_1556185707

A research-based global pharmaceutical company based in Windsor is seeking for a Senior Pharmacovigilance Officer. ProClinical is pleased to announce this exciting opportunity to work with a company dedicated to developing, registering, and commercialising novel and effective therapies that address patient needs and improve their quality of life.

The Senior Pharmacovigilance Officer will be responsible for ensuring appropriate handling, processing, reconciliation and submission of all in-bound and out-bound Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs) on marketed and development products, in an accurate and timely manner per international regulatory requirements and company standards. They will also oversee the writing, reviewing, and maintenance of global Pharmacovigilance Standard Operating Procedures (SOPs) and Working Instructions (WIs).

Job Responsibilities:

  • Handling and processing of spontaneous ICSRs and SAEs received for authorised and development products globally
  • Requesting and processing follow-up information for ICSRs and SAEs, as necessary
  • Quality control of processed ICSRs and SAEs prior to sending to Global Drug Safety
  • Sending processed ICSRs and SAEs to Global Drug Safety, and Ethics Committees as required
  • Performing and co-ordinating the reconciliation of ICSRs and SAEs exchanged between internal departments and third-party companies
  • Responsible for the review and triage of the Safety e-mail box
  • Assisting and advising all members of the Pharmacovigilance team as required to ensure compliance
  • Submitting Periodic Safety Update Reports (PSURs), periodic benefit-risk evaluation report (PBRER), Annual Safety Reports (ASRs) and Ethics Committee line listings as required
  • Co-ordinating, maintaining and delivering Pharmacovigilance training to all employees
  • Training Pharmacovigilance team members in specific Pharmacovigilance processes as appropriate
  • Writing, reviewing and updating of Pharmacovigilance SOPs and WIs
  • Ensuring the Pharmacovigilance team are appropriately trained and/or notified of all relevant SOPs and WIs generated by Global, and any other relevant SOPs/WIs in other departments
  • Completing and sending CAPAs to Global Drug Safety in the event of non-compliance to Global SOPS/WIs
  • Support the signal management process
  • Providing additional support for other Pharmacovigilance and Medical department activities as necessary

Skills and Requirements:

  • A scientific degree is essential and a higher degree desirable.
  • The candidate should have a minimum of 3 years' pharmacovigilance experience across the EU with US/International experience desirable.
  • The ideal applicant will need to have a thorough understanding of the regulations related to GVP and the quality management system.
  • The candidate should be highly motivated and self-directed, capable of multi-tasking and able to work with minimum supervision.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Divya Mistry at +44 20 3814 1315 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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