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Job Description

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.

Our team is growing and for this we need bright minds with creativity and flexibility - what talent do you have?

Accountabilities:

The Deputy EU QPPV is responsible for ensuring regulatory approval for new products and maintaining current product licenses and permits. This role involves monitoring regulatory developments and ensuring compliance. The EU Deputy QPPV will work closely with the EU QPPV and will support in the following:

• Act as a single pharmacovigilance contact point for the competent authorities in Member States and the Agency on a 24-hours basis and also as a contact point for pharmacovigilance inspections.

• Ensure establishment, maintenance and periodic accessibility and back-up procedure in absence or unavailability of the EU QPPV.

• Ensure the oversight of the PV Policy Intelligence (PVPI) activities for PV regulations and guidelines worldwide.

• Supervise the management of the EU- Pharmacovigilance System Master File (PSMF) team

• Ensure the oversight of the Pharmacovigilance System Master File (PSMF).

• Provide expertise on EU and global pharmacovigilance legislation and guidelines allowing processes compliance with changing regulations.

• Ensure quality of pharmacovigilance (PV) data submitted to the Health Authorities (HA: competent authorities in the EU/EEA member states and the Agency).

• Ensure full and prompt response to any request from HA.

• Provide input into the preparation of regulatory action in response to emerging safety concerns (variations, urgent safety restrictions (USR), communication to patients and healthcare professionals).

• Collaborate with Quality Assurance (QA) to ensure timely audit and inspection responses for the PSPV/GVSE function and assignment of appropriate ownership of corrective actions and preventive actions (CAPA) by PV subject matter experts (SMEs) for EU/EEA territories.

• Review, support, and approve key pharmacovigilance documents and reports as applicable, including but not limited to:

• EU Pharmacovigilance System Master File (EU PSMF), EU Risk Management Plan (EU RMP).

• Periodic Safety Update Report/Periodic Benefic Risk Evaluation Report (PSUR/PBRER).

• Post-Authorization Safety Studies (PASS) protocol and report, EU Summary of Product Characteristics (EU SmPC).

• Participate to meetings as appropriate, including but not limited to: PASS Review Meeting, NCPPV Forum, PSMF Forum, EU QPPV Team Meeting, Global Vaccine

• Safety Evaluation (GVSE) Meeting, Safety Management Team (SMT) Meeting.

• Collaborate with all PSPV functions.

• Collaborate with cross-functional departments, including but not limited to: Regulatory Affairs, Medical Affairs, Clinical, Medical Information, Quality, Manufacturing and Supply departments.

Education & Competencies (Technical and Behavioral):

• Medical degree preferred, and/or other professional Doctorate degree in Pharmacy or Sciences (MPharm, PharmD, MMed, MD, MBioMed).

• Excellent/significant knowledge respectively of EU/global PV regulations and guidelines.

• Professional experience of at least 10 years in pharmacovigilance.

• Previous experience as an EU QPPV, or deputy desired but not essential

• Prior experience with regulatory inspections with a focus on Pharmacovigilance

• Demonstrated strong leadership and managerial capability, with developed skills in team building, motivating and developing people and managing with a matrix environment

• Experience of operating in a multi-disciplinary drug development environment including international experience and exposure to a variety of therapeutic areas.

• Excellent communication and influential skills with strong written and presentation skills.

• Demonstrated in depth knowledge of regulatory agency requirements and expectations, particularly in the EU, regarding drug safety and an understanding of general drug safety methodologies.

• Excellent organizational skills and ability to prioritise and delegate activities with the ability to successfully manage multiple critical issues simultaneously

• Residing and operating in the EU/EEA (EU + Norway, Iceland, or Liechtenstein).

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