Senior Pharmacovigilance Compliance Officer

Highly Competitive
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United Kingdom
London
Posting date: 04 Feb 2019
DS.KH.21556_1549299449

ProClinical is advertising an exciting opportunity for a Senior Pharmacovigilance Officer Compliance position, joining a pharmaceutical company in London. Our client is a leading healthcare company that provides innovative, effective, and safe solutions that care for our clients at every stage of their life.

The Senior Pharmacovigilance Officer Compliance will provide expertise, along with strategy and a hands-on approach to setting up a regulatory compliant PV system.

Job Responsibilities:

  • Preparing global Pharmacovigilance related procedural documents.
  • Supporting the local Pharmacovigilance Responsible in the preparation of local PV procedures.
  • Leading the activities to maintain and further develop the PV processes and systems to ensure the global PV system is compliant.
  • Implementing CAPA (corrective and preventive action) and deviation management.
  • Maintaining a knowledge of both regional and EU legislation.
  • Preparing and maintaining the Pharmacovigilance System Master File (PSMF).
  • Providing input in the preparation of enquiries from the Regulatory Authorities as required.
  • Preparing, negotiating, and maintaining of Pharmacovigilance agreements.
  • Maintaining inspection readiness/audits, supporting timely execution and submission of responses to inspections/audits findings, and maintaining inspection/audit related documentation.
  • Managing PV compliance - preparing of ICSR compliance, aggregate reports compliance, and monitoring the implementation of the Risk minimisation measures, etc., as required.
  • Preparing training materials and delivering Pharmacovigilance related training for internal and external parties.

Skills and Requirements:

  • A bachelor's degree in life sciences, with equivalent experience considered.
  • At least 3 years of on-the-job experience in PV compliance.
  • Previous experience of preparing for and hosting PV inspections and audits is desirable.
  • Demonstrable experience of working to SOPs in a regulated environment.
  • Ability to work in an environment of rapidly changing priorities and workload; ability to manage multiple activities and assignments.
  • Ability to work both as a member of a team and in an independent, self-directed manner.
  • Ability to plan, multitask, and work in a dynamic team environment.
  • Communication, collaboration, persuasion, and problem-solving skills.
  • Strong team ethos, with a demonstrated track record of success in cross-functional teams and a fast-moving environment.
  • An ability to manage multiple projects simultaneously to ensure timely, on-target, and within budget accomplishment of tasks.

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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