"Astellas Pharma Hiring for Medical Assurance Professional in Bengaluru – Apply Now!"
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(Astellas Pharma Hiring Medical Assurance Professional Job 2025) |
Introduction:-
Astellas Pharma, a global leader in life sciences and pharmaceutical innovation, is inviting talented professionals to join its Global Capability Centre (GCC) in Bengaluru, India, as a Medical Assurance Professional.
This role is perfect for individuals passionate about pharmacovigilance (PV), drug safety, and medical quality assurance, who wish to build a strong global career in one of the world’s most respected pharma organisations.
If you believe in improving patient outcomes through scientific excellence and regulatory compliance, this opportunity could be your next big career step.
About Astellas Pharma:-
Astellas Pharma is a Japan-based multinational pharmaceutical company recognised for its commitment to innovation, patient-centricity, and global health improvement.
With operations across more than 70 countries, Astellas is at the forefront of developing and delivering cutting-edge treatments in oncology, immunology, urology, and rare diseases.
The Astellas Global Capability Centre (GCC) in Bengaluru is a strategic hub that drives global excellence in pharmacovigilance, medical affairs, clinical operations, and compliance functions, contributing to Astellas’ mission — “Changing tomorrow.”
Position: Medical Assurance Professional:-
Location: Bengaluru, Karnataka, India
Company: Astellas Pharma Global Capability Centre (GCC)
Department: Pharmacovigilance / Medical Assurance
This position offers an opportunity to ensure that Astellas’ marketed and investigational products meet the highest medico-scientific and regulatory standards worldwide.
You’ll be working closely with global PV teams, regulatory experts, and clinical operations to maintain the safety, quality, and compliance of Astellas’ medical data.
Key Responsibilities:-
As a Medical Assurance Professional, you will play a crucial role in strengthening global pharmacovigilance (PV) and medical quality systems. Your responsibilities include:
Supporting the development and execution of Medical Assurance objectives, ensuring alignment with PV Case Management and RAPV Operations.
Managing the Medical Assurance mailbox, triaging queries, and ensuring timely communication with both internal teams and external vendors.
Monitoring ICSR (Individual Case Safety Reports) for scientific accuracy, consistency, and compliance with global regulatory standards.
Maintaining and updating the Medical Concept Library and Expected Preferred Terms Lists (EPTLs) for accuracy in reporting.
Conducting biannual MedDRA updates and implementing process improvements within the safety and medical assurance domain.
Supporting labelling maintenance activities for both marketed and investigational Astellas products.
Participating in inspection readiness and managing non-conformances (CAPAs) to strengthen compliance frameworks.
Delivering training and guidance to internal and vendor teams to ensure excellence in medico-scientific case management.
Required Qualifications:-
A Bachelor’s degree in Life Sciences, Pharmacy, or related discipline.
At least 2 years of pharmacovigilance case processing experience (clinical or post-marketing).
A minimum of 5 years of experience in PV, QA, Regulatory Affairs, or Clinical Development.
Strong understanding of global pharmacovigilance regulations — including ICH, EU GVP, FDAAA, and JP guidelines.
Hands-on experience in MedDRA coding, safety data assessment, and quality compliance.
Excellent problem-solving, analytical, and communication skills.
Preferred Qualifications:-
A medical degree (MBBS, MD, or PharmD) is highly preferred.
Advanced knowledge of MS Excel, including formulas and macros, for data management and reporting.
Ability to work collaboratively in a cross-functional and global team environment.
Why Join Astellas Global Capability Centre (GCC), Bengaluru?
Working at Astellas GCC means being part of a world-class team driving innovation in pharmacovigilance and medical assurance.
Here’s what makes Astellas GCC one of the most sought-after workplaces in the pharma industry:
Global Exposure: Work directly with international PV and regulatory teams.
Scientific Excellence: Contribute to high-impact projects, ensuring global drug safety.
Learning and Growth: Continuous professional development through training and upskilling.
Career Advancement: Opportunity to move into leadership and global roles within Astellas.
Attractive Compensation: Competitive salary package with employee benefits.
Supportive Work Culture: A collaborative environment valuing transparency, innovation, and integrity.
How to Apply:-
Interested professionals can apply online through the official Astellas Careers portal.
Apply Now on Astellas Careers
Before applying, ensure your CV highlights your experience in pharmacovigilance, regulatory compliance, and quality systems — as these are key focus areas for this role.
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