Position Title: PV System Process Governance Analyst
Job ID: #25-PJT00295M
Location: Bengaluru, India
Employment Type: Full-time
About Astellas Pharma
Astellas Pharma Inc. is a leading global pharmaceutical company operating in over 70 countries worldwide. We are dedicated to turning innovative science into medical solutions that bring value and hope to patients and their families. Guided by ethics, integrity, and a focus on unmet medical needs, Astellas strives to improve global health outcomes and patient well-being.
Visit: www.astellas.com
About Astellas Global Capability Centres (GCCs)
Astellas’ Global Capability Centres (GCCs)—located in India, Poland, and Mexico—serve as strategic hubs that bring together diverse functions, talent, and core capabilities. These centres enhance operational efficiency, resilience, and innovation, driving the company’s strategic priorities and sustainable growth. GCCs are integral to Astellas’ mission of transforming scientific innovation into VALUE for patients.
Purpose and Scope
The PV System Process Governance Analyst supports the Pharmacovigilance (PV) System & Process Governance Team, ensuring effective maintenance of system configurations and continuous improvement in PV Transformation & Technology.
This role requires a blend of pharmacovigilance knowledge and technical expertise to align business needs with technological solutions, maintaining excellence in system governance and data integrity.
Key Responsibilities & Accountabilities
Maintain and manage business requirements for the global safety database, translating them into technical specifications.
Collaborate with technical system support teams to clarify, validate, and document both business and technical requirements.
Conduct testing and implementation verification, ensuring that all change requests are tracked and updated accurately.
Execute impact analyses to identify and mitigate risks such as missed case reports between effective and implementation dates.
Communicate system updates and changes clearly and effectively to all relevant end users.
Location
📍 Bengaluru, India
Required Qualifications
Bachelor’s degree (BA/BS) in a computer-related field or a healthcare discipline, or equivalent experience.
Minimum 5 years of experience in the pharmaceutical industry.
At least 2 years of hands-on experience working with Pharmacovigilance systems.
Preferred Qualifications
Advanced degree (Master’s or higher) in a computer-related or health technology field.
Strong understanding of PV database systems, change control, and system governance.
Why Join Astellas
Be part of a global, inclusive, and innovation-driven organization.
Work with a team committed to excellence in pharmacovigilance and patient safety.
Contribute to the mission of transforming innovative science into impactful healthcare solutions.
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