ICSR Workflow Efficiency Management Professional

2 weeks ago

Bengaluru, Karnataka, India Astellas Pharma Full time

Purpose And Scope
This role is responsible for implementation and maintenance of distribution rules and related configuration to support high compliance of ICSR submissions to HAs/BPs/CROs etc.

This role is responsible for robust and efficient system configuration management processes to establish a foundation for successful implementation of the current and future configuration changes.

Applying a combination of PV experience and technological knowledge, this role is responsible for combining business needs and technological possibilities and providing improvement and maintenance of excellence in ICSR submission activities.

This position is responsible for performing activities related to the ICSR Workflow Efficiency Management team.

Responsibilities And Accountabilities

  • Responsible for implementation and maintenance of distribution rules and related configuration for the safety data base.
  • Responsible for global regulatory and business partner reporting compliance, including outsourced activities.
  • Oversees the compliance of the outsourced activities to ensure corrective and preventive actions in case of non-compliance.
  • Responsible for the maintenance of business requirements regarding submissions in consultation with affiliates, interface team, case management team and QPPV (as applicable within the region).
  • Responsible for global mailbox procedures within the team.
  • Responsible for providing accurate responses to inquiries received from each stakeholder via email.
  • Maintenance of received business requirements for the safety database, translation into technical requirements and maintenance of the same.
  • Responsible for testing / implementation verification.
  • Support Audit & Inspection, support Non-conformance & CAPA activities.
  • Responsible for the execution of impact analysis to identify potential missed reports due to incorrect configuration and/or late configuration

Required Qualifications

  • BA/BS in computer-related field or higher education in healthcare discipline or equivalent experience
  • Minimum of 8 years of experience in the pharmaceutical industry
  • Minimum of 4 years of experience with Pharmacovigilance systems

Preferred Qualifications

  • Advanced degree in computer-related field is preferred
  • In depth understanding on safety data base configuration for reporting
  • In-depth knowledge and understanding of pharmacovigilance regulatory reporting requirements and guidelines in assigned region

Working Environment
Astellas' Global Capability Centres – Overview
Astellas' Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed.
_ _Our three GCCs are located in India, Poland and Mexico.
_ _

_ _The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
_ _

_ _Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company's strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
Category

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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