PV Country Lead

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Job Description

ROLE OBJECTIVE:

• Manage the Pharmacovigilance relationship within the local operating companies in the primary area of responsibility, which are Czech Republic and Slovakia.
• Act as the Local/National Contact Person for Pharmacovigilance (LCCPV) in both countries.
• 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 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 cluster.
• As such, the role requires effective leadership and partnership with the relevant stakeholders, both internally and externally.

ACCOUNTABILITIES:.

• Act as appointed local contact person for pharmacovigilance (LCPPV) in Czech Republic and Slovakia in accordance with the National Competent Authority (NCA) requirements. Meet all local NCA requirements to be nominated as LCPPV. Perform LCPPV 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 EU QPPV office, global PV organization, 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 local Contact Person for PV requirements for Czech Republic and Slovakia including education, local language capabilities, training, experience.
• Health professional or life sciences degree (Bachelor’s required; advanced degree preferred).
• Minimum 5 years of advanced experience in PV or related environments, preferably with demonstrated practice in local aspects. Regional / global experience is a plus.
• Excellent understanding and application of PV regulations and guidelines for the post marketing environment including local specificities.
• 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.

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