Deputy EU Qualified Person for Pharmacovigilance

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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 testing of 24/7 (hours/days) 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):

• Relevant degree in life and medical 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.

• Management and leadership skills as well as negotiations skills.

• Ability to communicate efficiently and timely orally and in writing in English.

• Permanently and continuously available.

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

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