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PV Auditor

Harlow
70,000
Permanent
Regulatory Affairs

Compass Life Sciences are partnered with a cutting edge CRO at the forefront of research across a wide variety of sectors and Pharma companies. With supported products varying from Covid-19 vaccines through to end-to-end PV support for Gene therapy, this is an incredibly exciting and diverse company with excellent prospects. Due to an ever-expanding portfolio and the increased general demand across the life science sector, our client is now actively seeking a Pharmacovigilance Auditor to support the current PV team and ensure compliance throughout all aspects of Pharmacovigilance.

More Info

Compass Life Sciences are partnered with a cutting edge CRO at the forefront of research across a wide variety of sectors and Pharma companies. With supported products varying from Covid-19 vaccines through to end-to-end PV support for Gene therapy, this is an incredibly exciting and diverse company with excellent prospects. Due to an ever-expanding portfolio and the increased general demand across the life science sector, our client is now actively seeking a Pharmacovigilance Auditor to support the current PV team and ensure compliance throughout all aspects of Pharmacovigilance.

The Pharmacovigilance Auditor is responsible for the management and conduct of pharmacovigilance audits for PV clients. They will also be responsible for the maintenance and management of the internal PV programme at DPV. Their role is to build and manage the auditing team at PV, and grow the auditing function within the business, utilising their expertise, knowledge and experience of best-practice methodologies and practices in industry. This role will work closely with the EEA QPPV/ UK QPPVs, and QMS Team Leader to ensure PV has a coherent plan for the provision of audits to DPV clients.

Main Responsibilities

People

  • Oversee and manage staff and contractors in the auditing team, holding regular 1-on-1 coaching sessions with direct reports.
  • Coach and guide staff in all aspects of PV auditing.
  • Establish and maintain a culture of active performance management of staff, including setting & agreeing objectives and reviewing performance.
  • Establish and maintain training and development programmes to increase staff capabilities and performance.
  • Review and forecast client demand from the team, maintaining resource plan to meet client needs.
  • Recruitment and onboarding of new staff into the team.
  • Develop succession plans for key roles in the team.

Operational

  • Act as a lead pharmacovigilance auditor and be responsible for the management and conduct of pharmacovigilance audits for PV clients.
  • Manage and maintain a schedule of audits for PV clients. Assist DPV clients with establishment of their audit universe and annual risk assessments for audit scheduling.
  • Assist in the recruitment and development of the auditing team.
  • Mange the internal PV programme and complete internal assessments as necessary.

Processes and Systems

  • Develop processes and procedures to ensure best practices are adhered to.
  • Work with the Client Leads to improve our client service and efficiency.
  • Ensure staff adhere to established company processes.

Coordination across PV

  • Collaborate with leads of other teams in Pharmacovigilance, to evaluate and improve our quality management.
  • Assess opportunities and be a key component in building the auditing business offering, participating in business development tasks and promotional activities.

Reporting

  • Oversight of the workflows in the auditing team.
  • Provide a monthly report to Directors on operational KPIs.

Skills

  • Excellent working understanding of all areas of Pharmacovigilance.
  • Strong communication skills.
  • Excellent organisational and prioritisation skills.
  • Effective decision maker.
  • Management experience.
  • A significant amount of experience working in Pharmacovigilance, with experience in the GVP auditing field.

This is role offers a fantastic opportunity to the right applicant, with great potential for development and promotion within an exciting company who are rapidly expanding across all Pharma sectors.

If you wish to apply, please contact David Jolley on +44 (0) 2393877358 or at [email protected]

Recommendations

Compass Associates Ltd. trading as Compass Life Sciences are acting as a Recruitment Consultancy for this permanent vacancy; we offer £200 worth of John Lewis Vouchers for each successful recommendation

Apply for the position of PV Auditor now with Compass Life Sciences

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