OVERVIEW:To ensure compliance with Good Pharmacovigilance Practice (GPvP)The PV Officer/QPPV is appointed as the management representative for the Quality Management System (QMS) for PV. He/she is responsible for ensuring the requirements of the QMS are implemented and maintained in an effective manner.KEY ACCOUNTABILITIES: Maintenance of the PV specific QMS and associated documentation (e.g. PSMF, SOPs etc) and records (e.g. deviations, change controls, audit reports).Act as system owner for the followingPV specificQMS components: Internal AuditsComplaints, Medical Information Enquires, Adverse Event ReportingDocumentation / SOPs / Literature Reviews/ Product Safety ReviewsDeviations and Non-ConformancesChange ControlCorrective and Preventative Actions (CAPAs)PSUR and RMP preparation and submissionTechnical Agreements and SDEA CollationConsulting with QPPV and medically qualified person on PV issues (when required)Review of ICSR process and reportsCollating all adverse reports from various sources including ASPR's, Literature Search and Spontaneous reportsElectronic reporting to Health AuthorityPharmacovigilance Training (Inclusive of company Site Wide PV Training)Provision of PV Activities for other specified MAH'SXEVMPD new licences population in EudravigilanceImplementation of European Medicines Agencies(EMA) Pharmacovigilance UpdatesDeputising for specified duties in absence of QPPV (as specified in Pharmacovigilance SOP'S)Participation in competent authority inspectionsEnsure regular meetings are held with the Quality Assurance Team and implement decisions taken at the reviews.Miscellaneous: To comply with Health and Safety Regulations.To maintain the confidentiality of all information relating to the business activities of the Company (and sister companies)To attend relevant courses as demanded by the CompanyTo perform other duties as directed by the CompanySKILLS/EXPERIENCE REQUIRED: Life Science Degree or several years' experience within a Pharmacovigilance departmentIndustry experience preferred.Desirable: Eudravigilance system experienceDue to the high volume of applications we receive we are not able to get back to everyone who applies. Therefore if you have not heard back from Experis within 7 days please assume that your application has been unsuccessful however we will contact you if suitable roles come up that match your skill set.