ICSR Workflow Efficiency Management Professional
Job ID: #1701
Location: Bengaluru, India
About Astellas
Astellas Pharma Inc. is a global pharmaceutical company operating in over 70 countries. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Our business is guided by ethics, integrity, and a focus on addressing unmet medical needs.
🌐 Visit: www.astellas.com
Global Capability Centres (GCCs)
Astellas’ GCCs—located in India, Poland, and Mexico—enable access to global talent and co-locate core capabilities across the value chain. These centres enhance operational efficiency, innovation, and resilience, helping Astellas respond effectively to evolving business demands.
Our GCCs are integral to Astellas’ strategic priorities, sustainable growth, and our mission to turn innovative science into VALUE for patients.
Position Overview
The ICSR Workflow Efficiency Management Professional plays a vital role in maintaining high compliance and operational excellence in Individual Case Safety Report (ICSR) submissions to Health Authorities (HAs), Business Partners (BPs), and Contract Research Organizations (CROs).
This position is responsible for implementing and maintaining distribution rules, ensuring robust safety database configurations, and supporting end-to-end workflow efficiency.
It requires a strong combination of pharmacovigilance expertise and technical understanding to enhance system performance and regulatory compliance.
Key Responsibilities
1. Configuration and Workflow Management
Implement and maintain distribution rules and related configurations within the global safety database.
Manage configuration change processes to ensure system robustness and compliance with global standards.
Translate business requirements into technical configurations for efficient and compliant ICSR submission processes.
Conduct testing and verification of configuration changes to ensure functionality and accuracy.
2. Compliance and Oversight
Ensure regulatory and business partner reporting compliance globally, including oversight of outsourced activities.
Perform impact analysis to identify missed or delayed reports due to configuration issues.
Drive corrective and preventive actions (CAPAs) in cases of non-compliance.
Support audits, inspections, and non-conformance investigations.
3. Collaboration and Communication
Liaise with affiliates, interface teams, case management teams, and the QPPV (as applicable) to maintain business requirements for submissions.
Manage global mailbox procedures and ensure accurate, timely responses to stakeholder inquiries.
Collaborate cross-functionally to maintain consistent, compliant ICSR workflow operations.
4. System and Quality Management
Maintain and update business and technical documentation for database configurations.
Support audit readiness by maintaining traceable and validated system configurations.
Contribute to the continuous improvement of system efficiency and data accuracy across PV operations.
Required Qualifications
Education:
Bachelor’s degree (BA/BS) in a computer-related field or higher education in a healthcare discipline, or equivalent experience.
Experience:
Minimum 8 years in the pharmaceutical industry.
Minimum 4 years of experience with pharmacovigilance systems and related technical configurations.
Preferred Qualifications
Advanced degree in a computer-related or technical field.
In-depth understanding of safety database configuration for regulatory reporting.
Comprehensive knowledge of pharmacovigilance regulatory requirements and guidelines for ICSR submissions within assigned regions.
Why Join Astellas
Be part of a global leader in life sciences innovation.
Work in a diverse, inclusive, and technology-driven environment.
Contribute directly to patient safety and regulatory excellence.
Collaborate with global teams to shape the future of pharmacovigilance systems.
Location: Bengaluru, India
Job ID: #1701
Apply Now: Astellas Careers – Apply Here
Note:
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or verified company email address. Report any suspicious activity to LinkedIn Help.
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