Senior Pharmacovigilance/ Deputy QP – London

Hendre Moolman is recruiting for a Senior Pharmacovigilance professional to work as a Deputy QP to join an expanding pharmaceutical company at their site in London on a permanent basis.

Responsibilities for this role include supporting the QPPV function locally and globally to ensure compliance with EU PV Legislation and EU Regulations and maintaining a robust compliance programme including company policies and Standard Operating Procedures (SOP’s).

To be considered for this rol you must have proven experience in Pharmacovigilance, at least 3 years QPPV office experience and expert knowledge of managing PSMF.

For more information on this role, or to apply, click here

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Clinical Safety Scientist – London

Farhad Salam is recruiting for a Clinical Safety Scientist to join a company in the pharmaceutical industry for a contract position in London.

In this position you will be required to support the continued safety monitoring and evaluation of assigned products in clinical development and/or post-marketing setting.

If you are experienced in Pharmacovigilence and have excellent communication skills, this could be a great opportunity for you.

Click here for more information or to apply >

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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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PV Systems Specialist- South East

Hendre Moolman at CK Cinical is recruiting for a PV Systems Specialist to join a company in the pharmaceutical industry in a 12 month fixed term role in the South East.

 Responsibilities

As PV Systems Specialist you will be responsible for supporting the Head of PV Systems to maintain validated Pharmacovigilance adverse event systems and provide technical expertise and training to Business Users for current and future PV system use, while acting as an interface between PV and IT and an interface between PV and software vendors.

Further responsibilities of PV Systems Specialist position will include:

  • Supporting the Head of PV Systems to manage change control and validation efforts to maintain validated Pharmacovigilance adverse event systems in compliance with Computer Systems Validation Policy and Computer Systems Validation Guidelines
  • Providing technical expertise  and training to Business Users
  • Working with Business Users to compile, validate and run searches of the database
  • Assisting Head of PV Systems in troubleshooting issues
  • Supporting local, regional and global users as system administrator as required
  • Working with Head of PV Systems to continue to develop EEL as the centre of excellence for electronic submissions
  • Reviewing and writing of relevant system administrator SOPs and WPs
  • Acting as back up to Head of PV Systems

 Qualifications

As PV Systems Specialist you will have the following qualifications, skills and experience:

    • Science Degree (e.g. pharmacy, Nursing, Life Science)
    • Relevant Pharmacovigilance experience
    • Extensive experience with adverse event database (ARISg preferred) and electronic (e2b) reporting systems (Cyclone preferred)
    • Experience with Reporting Applications such as Business Objects is required
    • CSV experience and understanding of Gateway Software, Company & Partner Profiles an advantage
    • Strong communications skills – with an ability to communicate technical issues to non- IT specialists
  • Excellent organisational skills to appropriately priorities workload including multiple projects

Benefits

As PV Systems Specialist 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
  • 12 month fixed term contract roleHendre Moolman - Pharmacovigilance Recruitment

How to apply

Apply online now

For more information or to apply for this PV Systems Specialist position please contact Hendre Moolman on +44 (0)1438 842 970 or email hmoolman@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.  Please quote reference CL25882 in all correspondence.

 Looking for a job in Pharmacovigilance

Click here to view CK Clinicals Pharmacovigilance jobs

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Senior Pharmacovigilance Scientist Job in London

Hendre Moolman at CK Clinical is currently recruiting for a Senior Pharmacovigilance Scientist to join a Pharmaceutical company based in London. This is a 12 month contract position.

Senior Pharmacovigilance Scientist Job Description

As Senior Pharmacovigilance Scientist, your primary objective will be to contribute and assist in EU QPPV pharmacovigilance activities, including PV system and processes oversight, compliance and Detailed Description of Pharmacovigilance Systems (DDPS). You will be representing the EU QPPV office and PV department internally and externally at a global level.

As Senior Pharmacovgilance Scientist, your key responsibilities will include:

  • Ensure that the EU QPPV has adequate oversight of the PV system including processes
  • Document the EU QPPV oversight of the PV system and its performance
  • Manage the Detailed Description of Pharmacovigilance Systems (DDPS) for updating and regulatory submissions
  • Maintain documentation necessary for EU QPPV office: mailbox, website, folders to ensure appropriate availability, and cross communication with all members of PV system
  • Review and carrying out and impact analysis (also solution proposals) on Health Authority proposals for changes in global pharmacovigilance regulations and guidelines
  • Collaborate with the Compliance Office in monitoring performance/compliance, training and receiving/distributing information as needed
  • Collaborate with the Compliance Office in Health Authority Inspections and internal audits
  • Contribute to SOP/SDEA review and writing
  • Contribute to improvement of departmental processes

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

  • Registered nurse or degree level qualification (e.g. Bachelors degree) in scientific/medical field
  • Proven experience in post marketing Pharmacovigilance plus any clinical experience
  • Experience with safety databases including simple searches & coding dictionaries (MedDRA)
  • Sound knowledge of clinical trial methodology and pharmacovigilance regulations (clinical and post marketing)
  • Ability to review, analyse, interpret and present data
  • Good level of computer literacy with Microsoft applications
  • Good organisation skills and ability to prioritise
  • Good communication and writing skills
  • Accuracy and attention to detail
  • Highly motivated and flexible
  • Ability to work in a team/matrix environment

How to apply:

Click here to apply online now.

To find out more about this Senior Pharmacovigilance Scientist position, please contact Hendre Moolman on 01438 870 023 or email hmoolman@ckclinical.co.uk.  Please quote reference CL23472 in all correspondence.

Click here to search our pharmaceutical jobs in London now.

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