Manager Pharmacovigilance

Proclinical is working with a innovative and creative pharmaceutical company that is seeking a Pharmacovigilance Manager to be based in Germany on a permanent basis.

Based on good understanding of EU regulatory requirements and of pharmacovigilance processes, the Junior Manager PV supports EU QPPV Office Manager to initiate, drive or contribute to improvement projects.

The Junior Manager PV provides effective (project) management support to the EU QPPV Office Manager in the maintenance of the PSMF and all other initiatives by the EU-QPPV office.

Also, the Junior Manager PV provides the required fundamental support to the PV Manager in the PV Region Europe (PVRE) for activities related to the management of Local Contact Persons for Pharmacovigilance (LPPVs) and Local Safety Managers (LSMs) appointed in various countries in Europe.

Job Responsibilties:

• Keep and improve EU-QPPV oversight
• Work on improvement and other initiatives with the EU-QPPV and with the Global Pharmacovigilance team. Collaborate with stakeholders globally to influence continuous improvement activities
• Partner with stakeholders across multiple functional lines globally to ensure high quality contributions to the PSMF delivered in a timely manner
• Author, develop, manage and archive the Pharmacovigilance System Master File (PSMF).
• Schedule, integrate, and coordinate stakeholder contributions and if required diligently follow-up to deliver PSMF according to regularly scheduled timelines, and on demand.
• Ensure PSMF is of high quality, inspection ready, reflects current business systems, processes, technologies, and organizational structures, and is in compliance with current EU legislation.
• Stay current with internal Pharmacovigilance systems, processes, and organizational structures and incorporate into PSMF
• Manage the EU QPPV office mailbox, organise team meetings and keep the records up to date in SharePoint.
• To support PVRE Manager in activities related to PVRE oversight of LPPVs and LSMs
• Collection, tracking and review of monthly LPPV reports, escalation of contents, if applicable
• Supporting PVRE team to maintain up to date SharePoint resources
• Scheduling and support with meetings, teleconferences and trainings
• Support with documentation related to above mentioned activities

To Apply:
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 call Herman Baer on + 41 78 679 7787 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.