Jobs of the Week: Pharmacovigilance – Hertfordshire

Krishna Pankhania at CK Clinical is currently recruiting for two roles within Pharmacovigilance. To find out more, please watch her short video or take a look at the job descriptions below…

 

Compliance and Training Manager Job in Hertfordshire, UK

Krishna is currently recruiting for a Compliance and Training Manager to join a Pharmaceutical company based in Hertfordshire.

Managerial Responsibilities:

  • Responsible for line management of direct reports.
  • Works flexibly with colleagues to ensure PV deliverables can be met while ensuring compliance and quality.
  • Holds staff appraisals and 121 meetings and regularly reviews progress.
  • Responsible for the performance management of direct reports.
  • Works with direct reports to create training and development plans for staff and regularly reviews progress. Works with direct reports to develop objectives.
  • Responsible for recruitment and retention of staff within own team.
  • Responsible for escalation and resolution of issues (departmental, client, authority or other party)
  • Authorship, review and/or approval of both Pharmacovigilance Departmental and project specific SOPs, working instructions and other procedural documents.
  • Contributes to, approves and implements CAPAs arising from inspections, external audits and internal audits.
  • Ensures back ups are in place to ensure smooth running of the department at all times.
  • Identifies need for new resource and communicates business case to Director PV.

Compliance and Training Management Responsibilities:

  • Works closely with Quality Director in the development and maintenance of the QMS.
  • Ensures adequate quality and compliance oversight of the work of the submissions team. Including all aspects of Eudravigilance, compliance submission of ICSRs and Aggregate reports on behalf of Clients.
  • Develops and implements standards within PV.

Skills and Experience:

  • Life Science degree or similar experience gained in Pharmaceutical Industry.
  • Experience in compliance related role within in a clinical research including PV.
  • CAPA management and SOP development experience required.
  • Experience of setting up training systems desirable.
  • Understanding of CSV and knowledge of safety databases desirable.
  • Good knowledge of PV regulations EU and USA
  • Experience of line management required
  • Good leadership skills
  • Ability to work under pressure.
  • Proactive approach to work
  • Project Management skills and ability to structure plans and ensure implementation
  • Good Team worker
  • Good organisational skills
  • Strong communication skills both verbal and written.
  • Ability to negotiate and influence

 

Pharmacovigilance Manager Job in Hertfordshire

Krishna is also recruiting for a Pharmacovigilance Manager to join a Pharmaceutical company based in Hertfordshire.  As Pharmacovigilance Manager you will act as the direct report to a medium sized team. Responsibilities will include:

General Responsibilities:

  • Communication with clients, regulatory authorities, ethics committees, investigational sitesand reporters and other client service providers.
  • Ensure client and patient confidentiality is maintained.
  • Operating at all times according to the appropriate SOP/procedural document.
  • Prioritisation of activities to meet departmental, client and regulatory time-lines.
  • Escalation of any issues that may impact on quality or compliance to the Pharmacovigilance Management Group and/or Manager Director.
  • Maintaining awareness of current and potential guidelines/legislation on pharmacovigilance and related matters, clinical trial guidelines and other relevant topics.
  • Maintain an accurate record of expenditure on external services.
  • Maintain a time sheet to accurately record time spent on client and departmental projects.
  • Any other reasonable task as requested by the Pharmacovigilance Management Group or Managing Director.
  • To act as back up to other members of the Pharmacovigilance Management Team when required.

Managerial Responsibilities:

  • Responsible for line management of direct reports.
  • Responsible for ensuring efficient and effective appropriate use of departmental resources.
  • Assists in financial forecasting and managing project level budgets.
  • Responsible for ensuring contract deliverables are met for all projects managed by direct reports.
  • Acting as part of the PV Management group, to ensure all services undertaken by Pharmacovigilance Department are run in adherence with applicable legislation and to quality standards.
  • Proactive and structured management of the PV department workload to ensure regulatory compliance and quality standards are upheld.
  • Working flexibly with colleagues to ensure PV deliverables can be met.
  • Anticipates, plans and prioritises activities in support of meeting project deliverables.
  • Holding staff appraisals and 121 meetings.
  • Working with staff to create training and development plans and regularly reviewing progress.
  • Working with direct reports to develop objectives and regular review of progress.
  • Recruitment and retention of high quality staff.
  • Responsible for prompt escalation of issues and assists in resolution (personnel, resourcing, departmental, client, authority or other party).
  • Facilitates preparation and participation in internal audits and inspections.
  • Contributing to, approval and implementation of CAPAs arising from inspections, external audits and internal audits.
  • Assists in development and implementation of a training system across PV.
  • Ensures back ups are in place to ensure smooth running of the department at all times.
  • Identifies need for new resource and communicates business case to Director PV.
  • Is accountable for delegation of tasks.
  • Encourages efficiency and effectiveness in solutions.

Skills and Experience:

  • Life Science degree or similar experience gained in Pharmaceutical Industry.
  • Extensive experience in PV across ICSR management, aggregate report writing and inspection preparation and participation.
  • Good knowledge of PV regulations EU and USA.
  • Experience of line management required.
  • Good leadership skills.
  • Ability to work under pressure.
  • Proactive approach to work.
  • Project Management skills and ability to structure plans and ensure implementation.
  • Good Team worker.
  • Good organisational skills.
  • Strong communication skills both verbal and written.
  • Ability to negotiate and influence.

 

How to apply:

For more information, or to apply for either of these roles, please contact Krishna Pankhania at CK Clinical on 01438 743 047 or email kpankhania@ckclinical.co.uk.

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