On behalf of our client, we are currently recruiting for a Qualified Person for Pharmacovigilance (QPPV). This person can be predominantly remote with occasional travel to Irish office. Purpose of Job Act as company nominated EEA QPPV to meet all EEA QPPV responsibilities (as defined in current EU Directive 2001/83/EC, GVP Module I and II). Limits of Role The post holder is not expected to authorise expenditure. If required, this will be in agreement with the Associate Director, Pharmacovigilance. Main Duties and Responsibilities The EEA QPPV is responsible for the functions described below and, where appropriate, in the client-specific job description. Overview of Safety *To have an overview of medicinal product safety profiles and any emerging safety concerns. *Have an awareness of any conditions or obligations adopted as part of the client MAs and other commitments relating to safety or the safe use of the product. *Ensure that signal management activities are conducted appropriately. Risk Management Plans *Have an awareness of risk minimisation measures. *Be aware and have sufficient authority over the content of risk management plans. *Be involved in the review and sign-off of protocols of post-authorisation safety studies conducted in the EEA or pursuant to a risk management plan agreed in the EEA. *Have an awareness of post-authorisation safety studies requested by an EEA competent authority including the results of such studies. Conduct of Pharmacovigilance *Ensuring conduct of pharmacovigilance and submission of all EEA pharmacovigilance-related documents are in accordance with the legal requirements and GVP. *Ensure the necessary quality including correctness and completeness of pharmacovigilance data submitted to the EEA competent authority. *Ensure a full and prompt response to any request from the competent authorities in the EEA member states and EMA. *Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g., variations, urgent safety restrictions, and communication to patients and healthcare professionals). *Act as a single pharmacovigilance contact point for the competent authorities in EEA Member States and EMA on a 24-hour basis and also as a contact point for pharmacovigilance inspections. Quality System *Have sufficient authority to influence the quality system and pharmacovigilance activities across the Company. *Have oversight of the information contained in the pharmacovigilance system master file (PSMF); to ensure it is an accurate and up-to-date reflection of the Companys pharmacovigilance system and pharmacovigilance metrics are recorded appropriately. *Conduct and lead Pharmacovigilance audits when applicable for clients and partners and respond to any deficiencies in conjunction with the MAH ensuring correct CAPAs are applied and completed. Local QPPV role *Act as National QPPV to support the client EEA QPPV in management of pharmacovigilance activities in Ireland. General Responsibilities Support the company and clients in pharmacovigilance meetings with authorities and or other relevant meetings. Mentoring and training of new and existing employees as required on Pharmacovigilance To act as a source of pharmacovigilance expertise for the Company All employees of have a responsibility under the Health and Safety at Work etc Act 1974 to ensure their own and others safety whilst at work and to be aware and work within the framework of company Health and Safety Policy and the associated Standard Operating Procedures. Qualifications and Role Requirements Life science degree, preferably within the sphere of pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology. A minimum of 5 years pharmaceutical industry experience. The EEA QPPV shall reside and operate in the EEA. For a full Job Spec and to apply for this role please call Linda on or e-mail Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: #LI-LD1 Skills: qppv pharmacovigilance