Krishna Pankhania at CK Clinical is currently recruiting for a Pharmacovigilance Manager to join a pharmaceutical company based in Hertfordshire, UK.
As Pharmacovigilance Manager, you will be part of a medium sized team and will act as the direct report to the team. Further responsibilities will include:
- 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.
- 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.
The ideal candidate:
- 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 this Pharmacovigilance Manager please contact Krishna Pankhania at CK Clinical on 01438 743 047 or email firstname.lastname@example.org. Please quote reference CL22897 in all correspondence.