Senior Pharmacovigilance Compliance Officer

  • Department: Pharmacovigilance
  • Location: Harlow, Essex
  • Education Level: University degree
  • Employment Type Level: Full Time
  • End Date: 27-Apr-2018

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Overview

About us...

We touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point. Yet until today, you may not have heard of us.

We’re Teva and we’re the company that supplies more medicines to the NHS than anyone else. We’re a fundamental part of the UK healthcare system.

We have the largest medicine cabinet in the world, but these days, people know more and expect more from their healthcare provider. People are taking a more active role in managing their health, through technologies such as smartphone apps, sensors and monitors.  They are looking to us for solutions, better health outcomes, information and support.


As a Senior Pharmacovigilance Compliance Officer, you will:

• Be responsible for the maintenance of the local Quality Management System, including maintenance of the Pharmacovigilance Controlled Documents (CDs) and training matrix and coordination of CDs and Pharmacovigilance training.

• Be responsible for the reconciliation with external stakeholders in an accurate and timely manner and according to local/regional and global regulatory requirements and company standards.

• Be responsible for the draft, review and management of Pharmacovigilance Agreements with third party licensors and PhV service providers within the UK, including maintenance of SDEAs tracker system and associated documentation.

• Be responsible for tracking Corrective and Preventive Actions (CAPA) for CAPAs raised from local and global Pharmacovigilance team and follow up with stakeholders to ensure timeliness completion and appropriate evidence is collected. 

• Support the Head of UK Pharmacovigilance (Local Safety Officer) /Deputy Local Safety Officer with preparation, conduct and reporting of third party audits as well as contributing to the preparation of regulatory inspections and ensuring oversight of compliance of UK specific activities.

• Ensure knowledge of UK Legislative requirements with regards to Pharmacovigilance and compliance with all Local and European safety regulations, advising Head of UK Pharmacovigilance (Local Safety Officer)/Deputy Local Safety Officer of any changes to local regulations in a timely manner


Skills & Experience

  • Bachelor’s Degree or equivalent (preferably in Life sciences)
  • Solid Pharmacovigilance experience or equivalent 
  • Excellent knowledge of applicable national Pharmacovigilance legislation
  • Broad appreciation of global regulatory requirements for Pharmacovigilance
  • Experience drafting and negotiating Pharmacovigilance Agreements
  • Involvement in drafting Pharmacovigilance training materials and conducting training to all internal stakeholders within Teva UK
  • Project Management skills: planning, organisational and time management skills
  • Thorough appreciation of the development and utilisation of performance and process metrics
  • Attention to detail
  • Commitment to follow Standard Operating Procedures
  • Good written and verbal communication skills

Main Responsibilities

Quality Management System:
  • Review and manage compliance with all relevant Global, European and Local SOPs and Working Instructions; suggest and implement changes or process improvements in the UK pharmacovigilance systems to ensure compliance with corporate and regulatory requirements
  •  Manage the introduction and maintenance of quality control processes and necessary corrective actions as identified
  •  Responsible for the preparation of metrics based in Key Performance Indicators defined by the Head of UK Pharmacovigilance (Local Safety Officer)
  •  Manage pharmacovigilance training delivery to Teva UK personnel, relating to regulations and procedures
  • Responsible for the maintenance of local and Global tracking systems related with the UK PhV Compliance activities
  • Support the Head of UK Pharmacovigilance in CAPA execution and collection of evidence to support agreed actions.
  • Responsible for the preparation of the Local Regulatory Intelligence report.

Audits and Inspections:
  • Assist in MHRA Pharmacovigilance inspections and third party audits, as necessary, and support other inspections and/or audits being performed elsewhere within Teva as required
  • Support the Head of UK Pharmacovigilance when performing audits to third party companies, including joining them during onsite audits and review the audit report
  • Preparation, conduct and reporting of Third Party Audits independently.

Safety Data Exchange Agreements:
  • Ensure that all required and appropriate Pharmacovigilance Agreements are in place and maintained with third party companies and other service providers.
  • Draft, negotiate and finalise Pharmacovigilance Agreements to as well as maintain the Pharmacovigilance Agreement management system by updating local tracker and notifying the relevant teams when a new/updated Pharmacovigilance Agreement is finalised. 
  • Perform timely adverse event reconciliation between Teva and 3rd parties companies according to the relevant Pharmacovigilance Agreements and provide the necessary administration and filling of the reconciliation process.