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DATE ADDED: Thu 04/07/2019

Pharmacovigilance Manager

Hitchin, UK
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JOB TYPE: Permanent

SALARY: £70000 - £80000/annum

A broad and varied PV Manager job opportunity managing a team of four to provide technical and operational expertise to implement the group's pharmacovigilance and customer complaints systems in accordance with regulatory requirements for medicines, medical devices and cosmetics.
Key Responsibilities
* Ensuring the performance of case processing, literature searching, signal management, adverse event reporting, surveillance reporting (PSURs, DSURs, PMSRs) and XEVMPD maintenance
* Overall oversight of all product safety and quality feedback from customers
* Ensuring that SDEAs are in place as necessary and that all internal and relevant third party personnel receive appropriate pharmacovigilance training
* Ensuring product benefit-risk is appropriately managed using risk management plans (medicines) and risk management files (other product classes)
* Ensuring the pharmacovigilance system is compliant with the company's Quality Management System
* Deputise for the Qualified Person Responsible for Pharmacovigilance
* Take responsibility for all aspects of pharmacovigilance during inspections and audits as required
Key Requirements
* At least a first degree in a life science or pharmacy
* Comprehensive technical knowledge and experience in pharmacovigilance for medicines essential, medical device post market vigilance experience would be an advantage but not essential
* Management and leadership
* Analysis and problem-solving
* Well organised and process-oriented
* Practiced and at ease with using computer data management systems
Role: Pharmacovigilance Manager
Job Type: Permanent
Location: Hitchin, Hertfordshire,

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