QPPV Team Lead


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

5th March 2021

Location

Athlone

Salary/Rate

£49698 - £63252

Type

Permanent

This job has now expired please search on the home page to find live IT Jobs.

My client, a well-established Pharmaceutical company based in Athlone, are looking for a QPPV to join their team.As QPPV, you would be responsible for establishment and maintenance of the Marketing Authorisation holder's pharmacovigilance system and therefore shall have sufficient authority to influence the performance of the quality system and the pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements. You will also lead the Pharmacovigilance team supporting 3 direct reports. Key Responsibilities as QPPV;Update and manage the company's Pharmacovigilance systems in line with legal requirementsManage and oversee external PV ProvidersOversee the maintenance of the PV system SOP's and the associated PSMFEnsure all PSUR and medical variation applications are planned, tracked and obtained in a timely mannerMaintain a program for audit pharmacovigilance system and Service ProvidersReview and update PV agreements for all contractual arrangements and ensure reconciliations are carried out as outlined in the agreementProvide Pharmacovigilance support and advice to relevant departmentsTrack and highlight updates to EMA and local drug legislation as it applies to EU and UK regulatory Pharmacovigilance requirements for investigational and post-marketing drug/biologic products Education & Experience;Degree in Pharmacy, Biology, Nursing, Toxicology, Medicine or an equivalent degree from the Life Science field3- 5 years of experience in Pharmacovigilance/Drug Safety/Medical Information within a commercial Pharmaceutical Environment (E)Demonstrable Expert knowledge in EU and UK PV legislation Experience in regulatory agency inspection planning, preparation, conduct, management and agency interactions To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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