Senior Safety Surveillance & Risk Scientist

Highly Competitive
  1. Permanent
  2. Product Vigilance
  3. United Kingdom
Cambridge, England
Posting date: 17 Jan 2020
DS.KH.27257

This vacancy has now expired. Please see similar roles below...

A well-known global pharmaceutical company with leading products across various therapeutic areas is looking to hire a Senior Safety Surveillance & Risk Scientist. This vacancy is an exciting opportunity to work at a top global pharmaceutical company that has a workforce of more than 6,700 employees across multiple sites in the UK.

Job Responsibilities:

  • Working collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians and play a leading role in delivering the safety requirements for your assigned drug project(s).
  • Ability to work collaboratively will facilitate cross-functional interactions with colleagues from across the company and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.
  • Leading the safety strategy for the assigned drug development programme, including aggregating, reviewing, analysing and interpreting safety-related data to generate information to support safety decision-making by prescribers, patients and payers, with the ultimate goal of protecting patients.
  • Leading all aspects of PV, including authoring and/or providing input to safety-related documents, e.g. regulatory periodic safety reports and safety content of marketing authorisation applications.

Skills and Requirements:

  • A life sciences/pharmacy/nursing degree; an MSc/PhD in scientific discipline preferred.
  • Demonstrable Patient Safety and/or Clinical/ Drug Development experience across a range of activities.
  • Demonstrable experience working in or leading safety &/or scientific activities in at least 3 of the following areas:
    • Clinical drug development (Early and/or Late Phase).
    • Post-Marketing Surveillance.
    • MAA/BLA submissions.
    • Periodic Reports.
    • Governance board interactions.
  • Risk Management Plans (authoring/working 'from scratch').
  • Strong working knowledge of PV regulations.
  • Good understanding of epidemiology preferred.
  • Fluent in written and verbal English.
  • 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 in computer skills, such as MS Office.

To Apply:

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 Kevin Hansberry at 0207 440 0636 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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