Senior Pharmacovigilance Risk Officer (Contract)

Highly Competitive
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United Kingdom
London
Posting date: 04 Feb 2019
DS.KH.21557_1549300338

ProClinical is happy to advertise an opportunity for a Senior Pharmacovigilance Officer Risk Management position for a leading healthcare company that provides innovative, effective, and safe solutions that care for our clients at every stage of their life. This is a contracted position with the company's team in London.

The Senior Pharmacovigilance Officer Risk Management will provide expertise and strategy, as well as a hands-on approach to safety surveillance and risk management.

Job Responsibilities:

  • Analysing the aggregate safety data from all sources, including EVDAS.
  • Setting up and maintaining the risk management system, including preparing the signal detection and risking minimalisation strategies.
  • Overseeing the timely planning, development, execution, submission, implementation, and maintenance of the Risk Management Plan(s), periodic aggregate safety reports (PSURs/PBRERs, and DSURs) and ad hoc safety reports.
  • Overseeing the Post-Authorisation Safety Studies (PASS).
  • Providing input in the preparation of enquiries from the Regulatory Authorities as required.
  • Preparing, negotiating, and maintaining Pharmacovigilance agreements.
  • Developing procedural documents around the performed PV activities.
  • Maintaining inspection readiness for audits and inspections; taking part in the preparation and helping conduct Pharmacovigilance inspections/audits; supporting timely execution and submission of responses to inspections/audits findings; maintaining inspection/audit related documentation.
  • Preparing training materials and delivering Pharmacovigilance training for employees.

Skills and Requirements:

  • A bachelor's degree in a Biological Science field, or related discipline.
  • At least 3 years of experience in all aspects of Safety Risk Management.
  • Experience of working to SOPs in a regulated environment.
  • Excellent medical writing skills.
  • An ability to work both in an environment of rapidly changing priorities and workload; an ability to manage multiple activities and assignments.
  • An ability to work both as a member of a team and in an independent, self-directed manner.
  • An ability to manage and organise work to meet timelines, and to meet the attention of detail requires to successfully complete assignments.
  • An ability to maintain client and corporate confidentiality; ability to effectively negotiate with individuals at all levels of business;
  • A thorough understanding of Good Clinical Practices is required.
  • Strong problem solving, persuasion, and negotiation skills; being able to execute solutions/deliverables in a timely manner.
  • An ability to establish rapport quickly, with a demanding and expert client base.
  • Excellent written and oral English skills, with other European languages a bonus.
  • A proven ability to focus and work with attention to detail, along with retaining critical information.

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 call Kevin Hansberry on +44 207 440 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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