Senior Pharmacovigilance Manager

Senior Manager Pharmacovigilance

After a singificant acquisition which has greatly increased the company’s portfolio, a new role for a Senior Manager of Pharmacovigilance has become available. This role will be crucial in creating a new system to manage the increase in portfolio.

The Pharmacovigilance manager will be supporting the EU-QPPV in the creation and maintenance of the new system.

About the Company:

A leading healthcare company who has seen significant expansion, and are looking to double their headcount in the next 3-5 years. They have 8 affiliates across Europe, including UK, Portugal, Spain, Italy, France, Netherlands, and Belgium. This positions can be based in any of these countries.

This is a great opportunity to enter a company at the best time for an expansion, really allowing you to put a significant footprint in how they grow, and allowing your career to grow at a fast pace.

Responsibilities:

• Work with the wider team to organize, manage and maintain a highly compliant Pharmacovigilance (PV) system
• Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities
• Maintains awareness and ensures adherence to as well as national and international regulations and guidelines for pharmacovigilance.
• Working to co-ordinate internal and external PV audits and inspections.
• Monitor PV system performance and compliance of partners and distributors.
• Helps to organize and coordinate vigilance training
• Helps to ensure the submission of all pharmacovigilance-related documents and data in accordance with the legal requirements and GVP;
• Has an oversight of the adverse reaction reporting system for medicines from collection, receipt, triage, assessment, processing and regulatory reporting.
• Provide input on the preparation of regulatory action in response to emerging safety concerns (e.g. safety variations, urgent safety restrictions, and communication to patients and healthcare professionals);

Experience:

• Appropriate qualification, with documented experience in all aspects of pharmacovigilance
• Education: looking for master’s degree in pharmaceutics, health care, life sciences or related fields
• 5 years of experience in a similar role, preferably in an international environment.
• Knowledge of QPPV tasks like RMP, SDEA, SPC updates, PSMF etc.
• Working knowledge of relevant EU and national legislation relating to medicines, and expert knowledge of good pharmacovigilance practice(s).