Senior Manager Pharmacovigilance

Proclinical is working with a global biotechnology company, that is seeking a Senior Manager Pharmacovigilance to provide assistance to the EU QPPV in managing the Pharmacovigilance System. Responsible for oversight of affiliates, distributors and vendors, and responsible for the oversight and maintenance of the Pharmacovigilance System Masterfile (PSMF). Reports to the EU QPPV.

Job Responsibilities:

• Work with the EU-QPPV to maintain an effective Pharmacovigilance (PV) System
• Responsible for maintaining and updating the PSMF and ensuring that the PSMF is of high quality, inspection ready, reflects current business systems and is in compliance with current EU legislation.
• Ensure monthly PV oversight report is received from local affiliates and distributors
• Review monthly report from local affiliates and escalate potential issues pertaining to the PV System to the EU QPPV.
• Manage the EU QPPV office mailbox
• Responsible for affiliate and distributor oversight for matters related to PV
• Responsible for PV vendor oversight and for working with legal affairs to ensure appropriate safety reporting language is included in the contracts with the vendors or, if applicable, ensure a Pharmacovigilance Agreement (PVA) is drafted and reviewed
• Provide safety reporting training to vendors, affiliates and distributors when required
• Ensure safety reporting training procedure and slide set content is up to date
• Write SOPs and Working Practices as applicable

Skills and Requirements:

• 3+ years' experience in Pharmacovigilance and experience of working with the QPPV office.
• Bachelor's degree in a biomedical science field such as pharmacy or nursing.
• Good medical/therapeutic area knowledge and medical terminology familiarity
• Knowledge of EMA safety reporting regulations
• Knowledge of GVP/GCP legislation and regulations
• PV Vendor management experience
• Experience working in a global capacity
• Experience with inspections: MHRA/FDA
• Writing training procedures and delivering training.
• Experience with post-marketing case processing
• Experience must include a proven understanding of the pharmacovigilance process and experience in leading projects to successful completion in a variety of environments.
• Excellent verbal and written communication skills, including formal presentations.
• Proficiency in Microsoft Excel, PowerPoint and Word required
• Sound organizational skills with the ability to prioritize tasks required
• Excellent interpersonal, team management and leadership skills required
• Experience with managing PV vendors, global affiliates and distributors, where applicable.

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 Jon Stewart on +44 203 7520 318 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.