PSPV Area Lead SEA & India

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 PV Area Lead, Southeast Asia & India (SEA-I) Location: India Southeast Asia and India are among the most diverse and dynamic pharmacovigilance environments in the industry. In this role, you'll set the pharmacovigilance strategy for the Area and lead the Local Patient Safety teams, keeping patient safety at the centre of how Takeda operates in every market. As the Area's main point of contact for safety matters and escalations, you'll work in close partnership with Global and Regional PSPV colleagues. You'll report to the PSPV Head, Asia Pacific, Middle East & CIS, as part of Patient Safety & Pharmacovigilance Affiliate Management (PSPV-AM) within R&D Data and Quantitative Sciences. How You Will Contribute Strategy & Leadership Define and lead the Area PV strategy, aligned with global and regional PSPV direction Set the Area's goals, KPIs and long-term plans, and build the PV capabilities needed to deliver them Lead and develop the Local Patient Safety teams, and build career paths for the next generation of PV talent Build strong, inclusive matrix partnerships across R&D and Commercial Compliance & Quality Be accountable for quality management and for PV compliance with local, regional and global post-marketing safety regulations across all countries and clusters Lead audit and inspection readiness and oversight, with Global PV Compliance and Takeda Quality Keep processes aligned and training compliance high, working with PSPV Compliance, Training and Alliance Operations & Resources Support the Area's PV budget, resourcing model and vendor partnerships Anticipate regulatory change and lead how processes adapt across the Area External & Internal Partnership Act as the Area's senior contact for safety issues and escalations, and as PV contact for the Health Sciences Authority (HSA) in Singapore, if applicable Serve as deputy Qualified Person for Pharmacovigilance (QPPV) or backup PV manager where needed Escalate to the Regional Head, and keep Medical Affairs, Regulatory Affairs, Quality Assurance and Compliance aligned on PV matters Partner with the PSPV-AM Patient Access and Vaccines Lead and Patient Access Programmes, and on vaccine safety discussions with National Health Authorities Skills and Qualifications Bachelor's degree required. An advanced degree in healthcare, life sciences or medicine is preferred. At least 10 years of pharmaceutical industry experience, including line management, with significant exposure to drug safety, clinical operations, R&D project management and local affiliates Advanced knowledge of PV operations, global safety regulations and business planning