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- Acting as the single point of contact for MHRA competent authority on a 24-hour basis.
- Ensuring the structure and performance of the pharmacovigilance system complies with applicable directives and current EU good pharmacovigilance practices modules.
- Provide expert inputs and review the pharmacovigilance procedures.
- Maintaining system oversight and overview of the safety profiles of all the products.
- Managing and monitoring the compliance of the pharmacovigilance system including timely submission of ICSRs and PSURs.
- Full university degree within the sphere of pharmacy, medicine, pharmaceutical chemistry and technology or biology.
- Suitable and demonstrable previous experience as a Qualified Person responsible for Pharmacovigilance within a multinational company environment. Experience in all areas of PV.
- Extensive pharmacovigilance and safety knowledge and practical experience in the Pharmaceutical / CRO industry.
- Demonstrable expert knowledge in EU PV legislation.
Qualified Person, Pharmacovigilance - Luton, Bedfordshire, United Kingdom - Life Sciences Recruitment
Description
My client specialises in the licensing and marketing cost-effective generic pharmaceuticals and is focused on growth through product launches and EU expansion. They want to increase their commercial foothold in the EU and expand their UK PV team.
Are you the right candidate for this opportunity Make sure to read the full description below.
They are looking for a QPPV to ensure constant compliance with UK PV Legislation and UK Regulations and maintain the company's Pharmacovigilance system. Being the main point of contact for MHRA competent authority.
Responsibilities:
At Life Sciences Recruitment Ltd (LSR), we are a Global Life Science recruitment firm that specialises in partnering with start-ups, and fast-growing biotech and pharmaceutical organisations. Founded in 2021, we recognised the need for a company with the insights, knowledge and credibility of a search firm but offering a contingent service. As one of the most competitive and fast-paced industries globally, succeeding and growing in the life sciences business requires a combination of creativity, technical expertise, and business savvy. At LSR, to find the best talent for your organisation, our dynamic recruitment consultants tap into our unparalleled network of contacts and apply a quality-based approach to a contingent search model tailored to your needs. We provide the most sought-after candidates to fit your requirements ranging from temporary placement to Fortune 500 companies LSR is a privately owned and independent recruitment company focused on the Life Sciences industry. We are a subsidiary of Morgan Prestwich (MP), Europe's leading boutique Life Sciences executive search and advisory firm. Contact us today to learn more about our recruitment services