PV Country Lead

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job Description:ROLE OBJECTIVE:Manage the Pharmacovigilance relationship within the local operating companies in the primary area of responsibility, which are Serbia, Montenegro, North Macedonia, Albania, Kosovo.Act as the Local Qualified Person for Pharmacovigilance (LQPPV) in Serbia.Maintain an efficient local PV system in compliance with the national regulations for medicinal products and with pharmacovigilance procedures.Provide PV functional expertise and support to all country operations within the Eastern Europe cluster in a matrix setup.Collaborate and liaise with Cluster Lead, cluster team and other global/regional functions to ensure appropriate systems/processes are in place to support the local PV system in the Eastern Europe cluster.As such, the role requires effective leadership and partnership with the relevant stakeholders, both internally and externally.ACCOUNTABILITIES:.Act as appointed local qualified person for pharmacovigilance (LQPPV) in Serbia in accordance with the National Competent Authority (NCA) requirements. Meet all local NCA requirements to be nominated as LQPPV. Perform LQPPV activities compliantly and stay trained to do so. Be the point of contact for PV related matters for global PV and in front of the NCAs, including audits and inspections.Manage and oversee the PV system in the primary area, including but not limited to compliance to all applicable global/regional and local legislative requirements, global PV processes, quality and compliance disciplines, business continuity.This includes working with the global PV organization, including but not limited to the EU QPPV office, local or global PV suppliers to implement PV strategies, and where appropriate ensuring a common understanding of the distribution of PV responsibilities and exercise oversight.Maintain an appropriate stakeholder network with non-PV colleagues and serve as a liaison in the assigned territory between mentioned stakeholders and PV organization. Act as the subject matter expert as it relates to applicable global, regional and local regulatory requirements, compliance and other factors.Identify potential gaps and quality events, initiate steps of CAPA development and completion. Support PV audits and inspections including follow-up.Ensure close collaboration with other PV personnel in the cluster in projects whenever needed. Act with best of knowledge, transparency and integrity to enable teamwork and business continuity.Support local companies within the cluster in collaboration and agreement with the appointed Cluster Lead when requested.Support National/Local PV Contact Person and Local Qualified Person for Pharmacovigilance (LQPPVs) activities where required in the cluster.Embrace the Takeda cultural mind-set of "Patient, Trust, Reputation and Business" in the workplace, undertaking personal accountability to live these values as we work as a team and represent our PV function inside and outside of the company, as appropriate.EDUCATION, EXPERIENCE AND SKILLS:Meets all applicable LQPPV requirements for Serbia including education, residency, local language capabilities, training, experience.Health professional or life sciences degree (medical, pharma, dental as required per law for LQPPV; advanced degree preferred).Minimum 5 years of advanced experience in PV or related environments, preferably LQPPV or deputy role (or direct support to these) in Serbia. Practice in local aspects of other European (EU and non-EU) countries, and/or other regional / global experience is a plus.Excellent understanding and application of PV regulations and guidelines for the post marketing environment including local and regional specificities and EU GVP.Excellent written/oral communication skills (local languages and English) and experience working within virtual teams. Understanding of medical/scientific terminology.Team worker with collaborative approach, having flexible mindset and high degree of cross-cultural awareness.Advanced experience of working cross-functionally (commercial, medical, regulatory and quality stakeholders).Well-developed organizational skills, ability to prioritise under pressure.Execute good documentation practices, have accuracy and attention to detail.High standard of computer literacy.LICENSES/CERTIFICATIONS:As required per LQPPV requirements.TRAVEL REQUIREMENTS:Travel infrequently required likely