PV Reporting and Information Management (RIM) Team Lead
Job ID: #25-PJT00292M
Location: Bengaluru, India
About Astellas
Astellas Pharma Inc. is a global pharmaceutical company operating in over 70 countries. We are dedicated to turning innovative science into medical solutions that bring value and hope to patients and their families. Our commitment to ethics, integrity, and unmet medical needs enables us to improve health worldwide.
🌐 Visit: www.astellas.com
Global Capability Centres (GCCs)
Astellas’ GCCs—located in India, Poland, and Mexico—enhance our operational efficiency, innovation, and resilience. These centres co-locate core capabilities, provide access to global talent, and are key enablers of Astellas’ sustainable growth and mission to deliver value to patients.
Position Overview
The PV Reporting and Information Management (RIM) Team Lead reports to the PV Transformation and Technology (PV T&T) Group Lead.
This role ensures the development, maintenance, and improvement of operational excellence in global pharmacovigilance (PV) systems and business operations. It combines PV expertise with technological insight to optimize reporting, system validation, and data governance.
The position leads the RIM Team and contributes to the long-term PV systems strategy, ensuring compliance with global regulatory requirements and Astellas’ internal policies.
Key Responsibilities
1. Strategy Development & Execution
Contribute to PV mission, objectives, and 3–5-year strategic plans.
Develop and maintain a long-term reporting strategy aligned with Astellas’ global information systems strategy.
Define a PV data governance framework to enable advanced data analytics.
2. PV System Validation & Compliance
Partner with QA and DigitalX teams to define validation strategies for PV IT systems (including RPA, AI, and cloud-hosted solutions).
Oversee System Life Cycle (SLC) validation for PV IT systems and global safety databases.
Ensure systems remain compliant with FDA 21 CFR Part 11 and international standards.
3. Reporting & Data Management
Ensure timely, high-quality outputs (line listings, tabulations, and reports) from PV IT systems.
Oversee data extracts for periodic reports and regulatory submissions.
Resolve reporting issues, assess impacts of system/process changes, and ensure data readiness for audits or inspections.
Maintain data integrity and manage validated data transfers for acquisitions/divestitures.
4. Process Improvement & Innovation
Lead cross-functional initiatives to integrate safety data across medical and development systems.
Identify and implement industry best practices for process optimization.
Facilitate technological upgrades and efficiency improvements in PV operations.
5. People & Organization Management
Build and manage a high-performing RIM team within a global matrix environment.
Provide coaching, performance management, and skill development.
Collaborate with internal and external stakeholders, ensuring effective communication and project alignment.
Qualifications
Required Education
Bachelor’s degree in Computer Science, Information Technology, or a Healthcare discipline.
Required Experience
10+ years in the pharmaceutical or related industry.
5+ years managing complex clinical or PV information systems.
3+ years in global safety database program management.
1+ year each in personnel and vendor management.
Proven experience with system validation, data governance, and reporting architecture.
Required Skills
Deep understanding of pharmacovigilance workflows and adverse event reporting regulations.
Expertise in system validation and report design for safety databases.
Strong project management, business analysis, and data interpretation skills.
Proficient in Microsoft Office and global communication (fluent in English).
Excellent leadership, collaboration, and multi-cultural communication abilities.
Willingness to travel internationally (up to 15%).
Preferred
Advanced degree in Science or Technology.
Prior experience managing or modernizing IT systems within a regulated environment.
Why Join Astellas
Work with a global leader in life sciences innovation.
Engage in transformative PV technology initiatives.
Collaborate in a diverse, inclusive, and future-focused workplace.
Be part of a mission to turn innovative science into VALUE for patients worldwide.
Location: Bengaluru, India
Job ID: #25-PJT00292M
Apply Now: Astellas Careers – Apply Here
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