Pharmacovigilance and Scientific Information Manager

4 weeks ago


Guildford, Surrey, United Kingdom Zentiva Group Full time
Be a Part of Our Winning Culture

At Zentiva Group, we value diversity and inclusion, creating a work environment where everyone feels appreciated and can contribute to the best of their ability. We are seeking a highly motivated and inspired Pharmacovigilance and Scientific Information Manager to join our team in the UK.

Main Responsibilities

Pharmacovigilance: As the UK National Contact Person for Pharmacovigilance (NCPP), you will maintain oversight of all UK PV cases, act as the primary PV contact person for the MHRA, and monitor compliance of UK PV case and aggregate report submissions. Additionally, you will author and maintain the UK pharmacovigilance system master file (PSMF), ensure the UK Qualified Person for pharmacovigilance (QPPV) is kept fully aware of all UK PV specific information, and be registered with and accessible to MHRA 24/7 in case of urgent safety situations.

Scientific Information: You will maintain oversight of Medical Information (MI) management, provide support to direct reports for complex medical enquiries, and ensure all MI SOPs/quality documents reflect the most efficient processes and are in line with regulatory and Zentiva global medical requirements. You will also lead and participate in any UK MI inspections and audits, and assist the Head of Scientific Affairs in fulfilling the ethical compliance function for the Affiliate.

Management of Resources: You will adhere to company-defined processes for the selection of and agreement of commercial terms with vendors, and understand and use internal procedures and tools to ensure the compliant and efficient operation of the "Purchase to Pay" process.

People Leadership: You will performance manage the team through setting and reviewing priorities, provide appropriate and timely feedback about performance, and coach team members to help them achieve their goals. You will also support the professional and career development of the team, lead the building of a motivated and engaged team, and encourage cooperation between individuals and teams.

Requirements

We are looking for a candidate with a life science degree or qualified Health Professional, 5-10 years' experience within pharmacovigilance, and previous line management responsibilities. We offer a competitive salary, additional benefit package, international working environment, and continuous learning and development opportunities.

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