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Job Description

Job Title: PV Country Lead - Indonesia and Vietnam

About the role:

• Manage and oversee the PV relationship within the Local Operating Company (LOC) to provide best Pharmacovigilance (PV) support and functional expertise to the LOC(s) within the assigned territory(ies), where applicable

• Support and provide pharmacovigilance oversight, functional expertise and leadership to the Local Patient Safety teams within their assigned Cluster

• Collaborate and liaise with relevant PV Area Lead and other PSPV functions to ensure appropriate systems/processes are in place to support the local PV system.

• In partnership with relevant PV Area Lead, defines and implements the local PV strategies as appropriate

• Act as point of contact for any safety related issues and escalation in the cluster.

How you will contribute:

• Manages and oversees the PV system in the assigned territory(ies) in accordance with local legislation and company requirements which may include but not limited to 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 relevant PV Area Lead to support and facilitate LOC PV interactions with other global sub-functions of PSPV.

• Maintains and influence appropriate stakeholder network with applicable Commercial BU, LOC and R&D to facilitate and implement PSPV strategies in collaboration with relevant PV Area Lead and serve as a liaison in their assigned territory(ies) to prevent gaps between Commercial BU, R&D functions and PSPV.

• Promotes pharmacovigilance and the safety of patients with key stakeholders and contribute in LAW and Medical Affairs workshops, Quality Councils, where applicable, in the assigned territories

• To be the SME of their assigned territory(ies) as it relates to applicable global, regional and local regulatory requirements, resourcing, compliance and other factors.

• With support from PSPV Compliance, and relevant PV Area Lead, manage audit/inspection preparation and lead the audit/ inspection within the assigned territory. Responsible for CAPA initiation and closure within the assigned territory(ies).

• Provide input to PV Area Lead on resource needs in the respective cluster to meet PV requirements of Takeda and support Patient Safety in the respective healthcare environment.

• Communicate all potential safety issues within the assigned territory(ies) immediately to PV Area Lead, PV Head GEM & applicable PSPV teams, as appropriate.

• Perform local QPPV and/or local PV contact person activities where required and trained to do so and ensures out of office coverage for PV related matters in LOC

• Oversee individuals within the assigned territory(ies) that perform pharmacovigilance activities, including those that do not report directly or indirectly to PSPV (vendors, contractors) as required.

• Works closely with MY/SG/PH Cluster Lead and where needed extends their support to broader I-SEA team, this may include some projects related to enhance patient safety in the respective cluster and I-SEA region.

What you bring to Takeda:

• Health professional of life science degree

• Bachelor’s required. Advanced degree preferred

• Relevant pharmaceutical or health care related industry experienced required

• Meets all applicable local QPPV / PV contact person requirements including education, training, 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

• Excellent written/oral communication skills (local language and English) and experience working within virtual teams

• 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 organizational skills

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Jakarta, IndonesiaHo Chi Minh City, Vietnam

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time