Astellas Hiring as a Medical Assurance (PV)

Astellas Pharma, a global leader in life sciences and innovation, is seeking a Medical Assurance Professional for its Global Capability Centre (GCC) in Bengaluru, India. This position offers an exciting opportunity to play a key role in pharmacovigilance (PV), regulatory compliance, and medical quality assurance, ensuring the highest medico-scientific standards for Astellas’ marketed and investigational products.

If you are passionate about drug safety, case management, and advancing patient outcomes, this role is designed for you.

Key Responsibilities

As a Medical Assurance Professional, you will:

• Support development and execution of Medical Assurance objectives aligned with PV Case Management and RAPV Operations.
• Manage the Medical Assurance mailbox, triaging queries and ensuring timely responses to internal and vendor teams.
• Ensure ICSR medico-scientific quality, consistency, and compliance with global regulations.
• Lead maintenance and updates of Medical Concept Library and Expected Preferred Terms Lists (EPTLs).
• Conduct biannual MedDRA updates and contribute to process improvement initiatives.
• Support labeling maintenance for Astellas’ marketed and investigational products.
• Participate in inspection readiness activities and manage non-conformances (CAPAs).
• Deliver training and guidance to internal and vendor personnel on medico-scientific case management.

Required Qualifications

• Bachelor’s degree in Life Sciences or equivalent.
• Minimum 2 years of pharmacovigilance case processing experience (clinical trial or post-marketing).
• At least 5 years of experience in PV, QA, RA, or clinical development.
• Strong understanding of global PV regulations (ICH, EU GVP, FDAAA, JP).
• Proficiency in MedDRA coding and safety data assessment.
• Skilled in problem-solving, process improvement, and ensuring quality compliance.

Preferred Qualifications

• Medical/Physician qualification (MBBS, MD, PharmD) preferred.
• Advanced Excel and data management skills (formulas, macros).

Why Join Astellas Global Capability Centre (GCC), Bengaluru?

• Be part of a world-class team driving innovation and compliance in pharmacovigilance.
• Gain exposure to global regulatory environments and cross-functional collaboration.
• Work in a culture that values quality, transparency, and scientific excellence.
• Competitive salary and benefits with opportunities for career advancement.

Application Process

Application Link