Pharmacovigilance Compliance Lead
A rapidly expanding pharmaceutical company is seeking to recruit a Pharmacovigilance Compliance Lead to their office in Cambridge. The organisation specialises in developing treatments for unmet medical needs. This position offers an exciting opportunity to bring expertise and skill to a highly prestigious organisation and bolster a career in the financial field.
- Responsible for the scheduling and management of the DS Compliance Meetings.
- Ensure PV related Key Performance Indicators (KPIs) and Key Compliance Indicators (KCIs) are defined for the PV systems overseen by MRL DS. This includes oversight of Corrective and Preventive Action (CAPA) for significant deviations and critical and major GVP audit and inspection findings.
- Act as Subject Matter Expert and Business Process Owner for Pharmacovigilance System Master File (PSMF) creation and maintenance.
- Provide PV Compliance advice to the company network of IACs.
- Support the maintenance of the MRL Quality System related to PV in accordance with relevant (national and international) legislation and GxP requirements.
- Support the EEA-QPPV to maintain the PV-system and ensure that all data and documents needed for EEA-QPPV oversight are available.
- Schedules and organises the DS Compliance Meetings, may chair meetings.
- Drive the maintenance and issuing of the PSMF.
- Oversee KPIs and KCIs and CAPAs for the service provider whilst performing PSMF compilation and management.
- Review and approve PSMF service provider's work invoices.
- Review output from service provider to ensure that it is fit for purpose and in line with the direction provided.
Skills and Requirements:
- Strong experience and knowledge of PV Compliance requirements and GVP.
- Strong experience of PSMF compilation and management.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kevin Hansberry at +44 207 440 0636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.