Pharmacovigilance Lead, Vmaps

About Takeda

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realise their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver **Better Health and a Brighter Future** to people around the world. Our Mission is to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine in our four core therapy areas of Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience, plus Plasma-Derived Therapies (PDT) and Vaccines.

**Role Purpose**

Due to an internal promotion, we have a fantastic opportunity for an experienced PV expert to join our team as the Pharmacovigilance Lead, VMAPS, responsible for a cluster of markets, including Vietnam, Malaysia, Philippines and Singapore.
- Where applicable, manage and oversee the Pharmacovigilance (PV) relationship within Local Operating Companies (LOCs) to provide best PV support and functional expertise to the LOC(s) within the assigned territory.
- Ensure compliance with applicable local legislations, company standards and procedures.
- Collaborate and liaise with PV Area Head, APAC and other GPSE functions to ensure appropriate systems/processes are in place to support the local PV system.
- In partnership with PV Area Head, defines and implements the local PV strategies as appropriate.

**Accountabilities**
- Manages and oversees PV systems in the assigned territory in accordance with local legislation and company requirements which may include but are not limited to conducting safety reporting and submissions, PV trainings, PV agreements and obligations, risk management plan implementations, cross-functional engagements, organized data collection programs, PV vendor/supplier oversight and management. This may include working with PV suppliers where appropriate and ensuring a common understanding of the distribution of the PV responsibilities is in place.
- Works closely with the Regional PVAR Liaison and PV Area Head to support and facilitate LOC PV interactions with other sub-functions of GPSE.
- Maintains appropriate stakeholder network with applicable Commercial BU, LOCs and R&D to facilitate and implement GPSE strategies in collaboration with PVAR Area Head and serve as a liaison in the assigned territory to prevent gaps between Commercial BU, R&D functions and GPSE.
- Serve as SME of the assigned territory as it relates to applicable global, regional and local regulatory requirements, resourcing, compliance and other factors and advise relevant stakeholders, including Commercial Leaders within assigned territory.
- Establish and support local and/or regional PV suppliers (e.g. local resident QPPV suppliers, PV services suppliers (including for business continuity) as required, including establishing appropriate oversight of such suppliers, if applicable.
- With support from Regional Process and Compliance Lead, and PVAR Area Head, manage the audit / inspection preparation and lead the audit / inspection within the assigned territory. Responsible for CAPA initiation and closure within the assigned territory.
- Communicate all potential safety issues within the assigned territory immediately to GPSE, GEM PVAR and PV Area Head as appropriate.
- Support LOCs within assigned territory in collaboration and agreement with the PV Area Head.
- Perform local QPPV and/or local PV contact person activities where required and trained to do so.
- Oversee individuals within the assigned territory that perform PV activities, including those that do not report directly or indirectly to GPSE (vendors and contractors), as required.

**Qualifications**

Education and Experience
- Bachelor degree in a life sciences field is required. Advanced degree preferred.
- Relevant pharmaceutical or healthcare-related industry experienced required.
- Meets all applicable local QPPV / PV contact person requirements including education, training and experience.
- Advanced experience, generally with at least 5 years in PV-related environments, preferably at local, regional and/or global levels.
- Understanding of medical/scientific terminology.
- Excellent knowledge of PV regulations for the post marketing global environment and applicable legislation.
- Experience working within and leading virtual teams.

Competencies
- Excellent written/oral communication skills (local language and English).
- Accuracy and attention to detail.
- Flexible mindset.
- High degree of cross-cultural awareness.
- Team worker with collaborative approach.
- Ability to prioritize under pressure.
- Decision making capability, and ability to independently resolve problems and conflicts.
- Well-developed organi