Pharmacovigilance Country Lead, Thailand

Pharmacovigilance Country Lead, Thailand



Pharmacovigilance Country Lead, Thailand

Job ID R0100749 Date posted Jul. 07, 2023 Location Thailand

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Job Description

Job Objective

  • Manage 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
  • Ensure compliance to applicable local legislations, company standards and procedures
  • Collaborate and liaise with relevant PVAR Area Lead and other GPSE functions to ensure appropriate systems/processes are in place to support the local PV system. As such, the role requires effective leadership and partnership with the relevant stakeholders, both internally as externally
  • The role requires effective leadership and day to day prioritization of pharmacovigilance (PV) tasks in order to meet the needs of the business and ensure compliance to all applicable local and global PV legislation and company procedures
  • In partnership with PV Area Lead, defines and implements the local PV strategies as appropriate
  • Where applicable, the PV Country Lead will also act as the local Qualified Person for Pharmacovigilance (QPPV) or Local Safety Responsible (LSR) as per the local applicable PV legislations


  • 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 conducting safety reporting and submissions, business continuity, 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 Thailand Lead to support and facilitate LOC PV interactions with other sub-functions of GPSE and with other LOCs within the assigned territory(ies), where applicable
  • Maintains appropriate stakeholder network with applicable Leadership teams, Commercial BU, LOC and R&D to facilitate and implement GPSE strategies in collaboration with PV Thailand  Lead, and serve as a liaison in their assigned territory(ies) to prevent gaps between Commercial BU, R&D functions and GPSE
  • 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
  • Establish and support local and/or regional PV suppliers (e.g. local resident QPPV suppliers, PV services suppliers (incl for business continuity) as required including establishing appropriate oversight of such suppliers, if applicable
  • With support from Regional Process and Compliance Lead, and PV Thailand lead, manage audit/inspection preparation and lead the audit/ inspection within the assigned territory(ies). Responsible for CAPA initiation and closure within the assigned territory(ies).
  • Communicate all potential safety issues within the assigned territory(ies) immediately to GPSE, Region Head, PVAR liaison and PV Thailand Lead as appropriate.
  • Support LOC(s) within assigned territory(ies), where applicable in collaboration and agreement with the appointed Cluster Lead.
  • 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.
  • Conducts PV training of all local PV employees, non-PV staff, all sites within the territory and where applicable
  • Line manage PV resources where appropriate, help organize resources for efficient functioning of the team, track performance of the PV team (where applicable) using the appropriate metrics


Bangkok, Thailand

Worker Type


Worker Sub-Type


Time Type

Full time
  • Job Type Full time
  • Job Level Senior
  • Travel Minimal

Within Takeda’s Data Sciences Institute, we harness the insight of data and digital to speed the development of new medicines to patients. The Data Sciences Institute (DSI) is primarily focused on getting medicines to patients faster through innovation and efficiencies driven by data and analytics.

We nurture a culture that encourages disciplined risk-taking, supports innovation, values diversity and emphasizes implementation.

We want to hire and develop the best talent to join us on our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine!

  • Work with various data sources
  • Apply a breadth of methodologies
  • Develop analysis pipelines
  • Design studies

Where You Fit In

When you join our Data Sciences Institute team, you’ll connect with a diverse and talented group of scientists, engineers and analysts. Together, you’ll define cutting-edge algorithms, conduct pharmacology-based modeling and explore new approaches to data services. In a collaborative environment marked by strong, open and honest leadership, you’ll take charge of your professional advancement as you work on important projects that grow your skills and lead to ongoing opportunities.

A career within the Data Sciences Institute at Takeda will give you everything you need to succeed professionally. You’ll see up close that what you do with information and insight has the power to impact the lives of patients — today and for generations to come. Working here, you’ll understand that our people-first perspective extends beyond patients to include our Takeda team, our families and the communities where we all work and live.

The energy, professionalism and commitment that I experienced in every encounter, from the interview process to meeting with my manager to receiving an offer, left me feeling a certain level of consistency and thoughtfulness. That made me feel really enthusiastic.

Brian Johnson Head, R&D Technology,
Data Sciences Institute

Being able to predictably deliver on our portfolio priorities is where we have laser-focus each and every day. By doing this, we keep our eye on the prize of bringing new medicines to patients, and show the value that these treatments can bring to their lives.

Simon Davies Head, Statistical & Quantitative Sciences
Data Sciences Institute

We're using the newest technology and methods, like wearable devices and machine learning, to better understand the health of patients participating in our trials.

Ariel Dowling Head, Sensing & Measurement,
Digital Health Sciences

Our Pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

Learn More

What We Believe In

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

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Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.

  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.

  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

View All Data Science Institute Jobs


We Take Action by Focusing on Our Four Priorities

  • Create an exceptional people experience
  • Responsibly translate science into highly innovative, life-changing medicines and vaccines
  • Protect our planet
  • Unleash the power of data and digital

About our location

, Bangkok

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