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Product Surveillance Specialist

BuckinghamshirePermanent
Experience Dependant
Job Reference: J5632952
Updated On: 21/02/2020
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Medical Device

Skills: Quality Assurance - Compliance, Engineering - Medical Devices, Pharmacovigilance - PV - Perm, Pharmacovigilance - PV Manager

Job Information

Role Overview

We are currently looking for a Product Surveillance Specialist to join a leading Global Pharmaceutical company based in the Buckinghamshire area. As the Product Surveillance Specialist you will be responsible for the Vigilance reporting of adverse events linked to the companies Medical Device portfolio.

You will manage all aspects of the complaint handling process from initial reporting through to report submission to Regulatory bodies such as the MHRA. This is a senior level position and would suite a person with previous experience of Pharmacovigilance or Medical Device Vigilance who is looking to gain experience in process improvement.

Key Duties and Responsibilities

Your duties as the Product Surveillance Specialist will be varied however the key duties and responsibilities are as follows:

1.You will work closely with the Vigilance Reporting Analysts with reporting activities as required including the review and approval of Vigilance reports in the complaint handling system.

2. Have direct contact with the Competent Authorities and Notified bodies where you will lead the response to questions. Responsibilities here include data extraction, report requests and analysis of quality data. You coordinate the efficient and compliant response.

3. You will assist the Team Manager with Process Improvement activities including assessment of the complaint handling system and review of KPIs and reporting matrics.

4. Assist with the Quality Management System including maintaining training files, archiving customer complaints and adverse events as well as raising CAPAs and deviations as required.

Role Requirements

To be successful in your application to this exciting opportunity as the Product Surveillance Specialist we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Sciences discipline or experience in a similar environment including the Healthcare, Medical Device or Pharmaceutical industry.

2. Proven industry experience in Adverse Event handling or vigilance reporting, ideally in accordance with MEDDEV regulations.

3. Previous experience of leading interactions with Competent Authorities or Notified Bodies will benefit your application.

Key Words: Product Surveillance Specialist | Vigilance Reporting | Adverse Event | Pharmacovigilance | Medical Device | MEDDEV | Medical Device Directive | 93/42/EEC | Medical Aesthetics
Georgia Walden
Your Recruitment ConsultantGeorgia WaldenGeorgia.walden@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.