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2017-41523

2017-41523

Title 
Director of Safety Risk Management
Job Locations 
-
United Kingdom-Reading
United Kingdom
Posted Date 
6/26/2017

More information about this job

Overview

PRA Health Sciences is excited to offer new opportunities within our new strategic partnership agreement with a global pharmaceutical company. 

 

We have a new opening for Director of Safety Risk Management to join us supporting our global embedded team based out of their Central London head-quarters.

 

This innovative partnership provides an operating model that combines operational expertise with PRA's wide range of global capabilities. This flexible approach will facilitate the development of new medicines by focusing resources, teams and activities where needed, an important requirement for an industry-leading, highly agile R&D organisation focused on meeting patient needs.

 

This is a permanent opportunity, office based in Central London with the option to work 2 days from home after an initial training period.  

Responsibilities

What will you be doing? 

 

Embedded within our newest strategic partner and reporting to the Executive Director of Safety and Risk Management, you will be a qualified physician and have considerable experience in pharmacovigilance, clinical research or clinical development. Your experience with line management allows you to take over line management responsibilities.

 

As the Director of Safety Risk Management you will support developmental programs, including both early and late stage development as required. You will be responsible for the oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead responsibly as appropriate. You will support the Therapeutic Lead and you will have line management, training and mentoring responsibilities for junior physicians and/or scientists, serving in a leadership capacity for complex and strategically important programs.

  • You will be one of the medical safety experts and assume assigned compounds’ responsibilities. You will lead Global Pharmacovigilance Safety Management Teams to perform routine safety surveillance and cross-functional Safety Management Teams to review important safety issues, determine changes in the benefit/risk profiles and decide on appropriate actions related to the assigned compounds. You will be responsible for development of documents and be involved in negotiations with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, involvement of authoring of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs etc. The final review and signature of documents remains solely with the client.
  • You will perform regular safety and efficacy review for designated products across the width of relevant safety information (e.g. FDA AERS, WHO Vigibase, pre-clinical, clinical, safety data including SUSAR, epidemiological, spontaneous, literature & regulatory alerts, other scientific data)
  • You will contribute to, review and approve updates to PSUR/PBRER, six-monthly and other periodic reports, ACO etc.
  • You will apply pharmacoepidemiological approaches to solving safety issues; including direct utilization of data-mining tools, as necessary, to elucidate and analyse potential safety issues
  • You will contribute to the preparation for and conduct of inspections and audits
  • You will maintain professional knowledge and accreditation by active participation in continuing medical education activities.

Qualifications

What do you need to have? 

 

Education:  Qualified physician (Licence, e.g. GMC registered, preferred)

 

Skills: 

  • Considerable experience in pharmacovigilance, clinical research or clinical development
  • Moderate clinical experience with patients following post-graduate training with significant knowledge of general medicine
  • Knowledge of principles of epidemiology and statistics
  • Critical thinking and analytical skills and ability to make high level decisions
  • Excellent oral and written communication skills including ability to present to large internal/external groups
  • Good level of computer literacy with Microsoft applications
  • Experience managing others

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities.

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