PV System Process Governance Analyst

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

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

Purpose and Scope:

This role is responsible for supporting activities around the maintenance of system configuration management.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 PV Transformation & Technology. This position is responsible for performing activities related to the PV System & Process Governance Team.

Responsibilities and Accountabilities:

• Maintenance of received business requirements for the Safety Database, translation into technical requirements and maintenance of the same.
• Responsible for collaboration with the technical system support team to clarify business and technical requirements.
• Responsible for testing / implementation verification and keep requests up to date
• Responsible for the execution of impact analysis to identify potential missed reports during the effective date and implementation date.
• Responsible for end-user communication of implemented changes

Required Qualifications:

• BA/BS in computer-related field or higher education in healthcare discipline or equivalent experience
• Minimum of 5 years of experience in the pharmaceutical industry
• Minimum of 2 years of experience with Pharmacovigilance systems

Preferred Qualifications:

• Advanced degree in computer-related field is preferred