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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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.

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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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Pharmacovigilance Manager – London

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

Responsibilities

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

Further responsibilities of this Pharmacovigilance Manager position will include:

  • The documentation and processing of reports of adverse drug reactions.
  • 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
  • Preparation of PSURs
  • Preparation and maintenance of 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 Manager you will have the following qualifications, skills and experience:

  • Solid pharmacovigilance experience
  • Degree in life sciences discipline / background in nursing
  • Excellent understanding of medical terminology.
  • Experience in the interpretation of medical and scientific literature.
  • Experience in searching medical literature databases (e.g. PubMed)
  • Computer literate (primarily Word, Excel, Power Point)
  • Basic understanding of Quality Management Systems and working with Standard Operating Procedures (SOPs)
  • Excellent written and verbal communication skills.
  • Excellent interpersonal skills with the ability to work with a number of different clients according to their various
  • requirements.
  • Good knowledge of the rules governing medicinal products in the EEA, including the legislation governing the pharmacovigilance requirements.
  • Well organised, efficient and self-motivated with the ability to work to tight deadlines within a small company environment.
  • Car driver essential due to location

Desirable but not essential:

  • Experience/knowledge of the preparation and maintenance of Pharmacovigilance System Master Files (PSMFs)
  • 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 Manager 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
  • Permanent roleHendre Moolman - Pharmacovigilance Recruitment

How to apply

For more information or to apply for this Pharmacovigilance Manager position please contact Hendre Moolman on +44 (0)1438 842 970 or email hmoolman@ckclinical.co.uk.  Please quote reference CL25912 in all correspondence.

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