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Safety Review Pharmacovigilance 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.

Overall Job Purpose:

To assist in the review of Company Core Safety Information against national labelling (SmPC/PIL)
Monitor the implementation of safety variations into national labelling
To assist in the development, review and implementation of safety activities relating to Risk Management Plans (RMP)
To assist in the process of handling and responding to ad hoc safety issues related to UK marketed products
To assist in the delivery of face to face Pharmacovigilance training to relevant personnel in product/therapeutic areas and risk minimisation activities relating to safety
Safety activities to be performed in accordance with international regulatory requirements local and global Standard Operating Procedures and Working Instructions
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
Ensure Global Patient Safety & Pharmacovigilance is advised of UK safety regulatory requirements that have an impact on Pharmacovigilance System.
To support any process optimisation initiatives within cluster region in support of the business objectives.

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 in Risk Management and Safety review

• Excellent at priority setting

• Attention to detail

• Commitment to follow Standard Operating Procedures

• Computer and database skills

• Good interpersonal and people skills

• Good written and verbal communication skills

• Ability to demonstrate pro-activity

Main Responsibilities

Company Core Safety Information:

§ Perform comparisons of Company Core Safety Information (CCSI) and national UK SmPCs, including liaison with UK Medical Affairs and Regulatory Affairs, as necessary

§ Assist in the identification of potential safety variations to UK national SmPCs required, following discussion with relevant personnel as necessary e.g. UK Medical Affairs, UK Regulatory Affairs and the Global PSUR Writing Centre

§ Perform the review of all notifications received from the CCSI Distribution System (DS)

§ Maintain the Safety Variation Tracker with respect to UK related Safety Variations.

§ Perform the creation of safety variation changes in the Teva Change Control system for national UK licensed marketed products.

Risk Management:

§ Assist in the implementation and monitoring of safety measures relating to European or UK- specific RMPs

§ Assist in the alerting of all relevant UK personnel to specific RMP requirements as necessary e.g. Medical Affairs, Regulatory Affairs, Marketing, Launch team

§ Assist in the review of RMP materials that are Conditions of the Marketing Authorisation prior to implementation, liaising with UK Marketing and Medical Affairs, as necessary

§ Liaise with the MHRA regarding the RMP measures relating to Teva marketed products, as necessary

§ Assist in the maintenance of the Risk Management Tracker for all licenced products.

Training

§ Assist in the preparation of specific training on RMP measures (for specific products or in general), as required

§ Prepare and document pharmacovigilance training on product/therapeutic areas to relevant personnel.

Ad hoc safety issues/review:

§ Assist in preparing and reviewing actions and responses of ad hoc safety issues received internally and from Regulatory Authorities

§ Conduct Health Hazard Assessments for Teva products working closely with internal and external stakeholders.

§ Interact with Global Patient Safety and the European Qualified Person as necessary in the performance of this role.