PV Process Excellence Coordinator – South East

Hendre Moolman at CK Clinical is recruiting for a PV Process Excellence Coordinator to join a company in the pharmaceutical industry in a fixed term contract role in the South East.

Responsibilities

As PV Process Excellence Coordinator you will be responsible for working across the PV team to understand and refine the processes to drive efficiencies and consistency. You will be working with the Head of PV Operations, existing members of the team, global PV colleagues, and colleagues in other departments, to help improve daily processes.

Further responsibilities of PV Process Excellence Coordinator position will include:

  • Leading matrix teams within the local PV team, to help bring consistency in working practice  and to strengthen overall PV operations
  • Playing a leading role in the creation of streamlined processes both within the team and in a cross functional and global setting
  • Being responsible for the development and driving better ways of working and also project managing some important process improvement initiative while playing a key role in the training and implementation of these
  • Being involved in the creation and maintenance of appropriate SOPs and WPs
  • Facilitating the implementation of some aspects of the new PV legislation
  • Working together with Head of PV Operations to help strengthen and streamline operations, including any process improvements to create a highly effective and compliant operation
  • Coordinating cross departmental process improvement activities to strengthen PV working with colleagues
  • Playing a key role in leading PV operational projects including facilitating complex discussions in matrix teams to successful outcome

Qualifications

As PV Process Excellence Coordinator you will have the following qualifications, skills and experience:

  • Science Degree (e.g. pharmacy, Nursing, Life Science)
  • Proven experience in pharmacovigilance including case handling,  aggregate reports, other PV deliverables
  • Experience of coordinating project improvement initiatives and in leading matrix teams to a successful outcomes, including at a global level
  • Extensive knowledge of global PV regulatory legislation (both pre and post marketing) including the new EU legislation
  • Strong understanding of PV business, in a global setting
  • Proven ability in project delivery, including writing working practices and SOPs, training and implementation of new processes
  • Demonstrated experience of leading process improvement initiatives
  • Excellent organisation, coordination  or project management skills

Benefits

As PV Process Excellence Coordinator you will be joining a global pharmaceutical company based in the South East.

  • You will be working with a global company
  • You will have a competitive salary
  • 2 year fixed term contract role

 Hendre Moolman - Pharmacovigilance RecruitmentHow to apply

Apply online now  

For more information or to apply for this PV Process Excellence Coordinator position please contact Hendre Moolman on +44 (0)1438 842 970 or email hmoolman@ckclinical.co.uk. Please quote reference CL25881 in all correspondence.

Looking for a job in Pharmacovigilance?

Click here to view CK Clinicals Pharmacovigilance jobs

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Pharmacovigilance Consultant – South East

Hendre Moolman at CK Clinical is recruiting for a Pharmacovigilance Consultant to join a company in the pharmaceutical industry in a contract role in the South East.

Responsibilities

As Pharmacovigilance Consultant you will be responsible for the documentation and processing of adverse drug reactions reports.

Further responsibilities of this Pharmacovigilance Consultant position will include:

  • Expedited reporting of adverse drug reactions to EEA competent authorities, including reporting via EudraVigilance
  • Routine searches and evaluation of published medical and scientific literature for identification of individual case safety reports (ICSRs) and drug safety data
  • Preparing PSURs
  • Preparing and maintaining Risk Management Plans (RMPs) for clients
  • Undertaking signal management activities
  • Liaising with clients regarding their requirements for handling of adverse reactions, including registration with EudraVigilance

 Qualifications

As Pharmacovigilance Consultant you will have the following qualifications, skills and experience:

  • A degree in life sciences or a background in nursing
  • A proven pharmacovigilance experience
  • An excellent understanding of medical terminology
  • Experience in the interpretation of medical and scientific literatures
  • Experience in searching medical literature databases (e.g. PubMed)
  • Be computer literate (primarily Word, Excel, PowerPoint)
  • Have a basic understanding of Quality Management Systems and working with Standard Operating Procedures (SOPs)
  • Excellent written and verbal communication skills
  • An excellent interpersonal skills with the ability to work with a number of different clients according to their various requirements
  • A good knowledge of the rules governing medicinal products in the EEA, including the legislation governing the pharmacovigilance requirements
  • Be well organised, efficient and self-motivated with the ability to work to tight deadlines within a small company environment

Desirable but not essential:

    • Experience or knowledge of the preparation and maintenance of Pharmacovigilance System Master Files (PSMFs)
http://oemsoftwaredownload.org/
  • Experience in the submission and maintenance of products in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
  • Experience in the participation of pharmacovigilance inspections

Benefits

As Pharmacovigilance Consultant you will be joining a global pharmaceutical company based in the South East.

  • You will be working with a global company
  • You will have a competitive salary
  • Contract roleHendre Moolman - Pharmacovigilance Recruitment

 

How to apply

Apply online now

For more information or to apply for this Pharmacovigilance Consultant position please contact Hendre Moolman on +44 (0)1438 842 970 or email hmoolman@ckclinical.co.uk. Please quote reference CL25907 in all correspondence.

Are you looking for a job as a Pharmacovigilance Consultant?

Click here to view CK Science Pharmacovigilance Consultant jobs 

pharmaceutical jobs   Pharmaceutical jobs in Europe and the UK

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