ICSR & Literature Procedure Management Professional

Purpose And Scope

• Responsible for ICSR & Literature Procedure Management by ensuring up to date and best practice global processes and procedures and training, as well as continuous improvement of ICSR & Literature process activities.
• Where do they collect it from
• Who will they be training
• Reports to the Team Lead, Literature Management & Global Governance. Contributes to the implementation and successful execution of the PV Case Management objectives and 1-3 year operational plan, supporting the overall RAPV mission.
• Responsible for global consistency of ICSR & Literature processes and procedures and global ICSR & Literature training programs. Develops procedures for cross-functional activities related to ICSR & Literature in collaboration with global and regional stakeholders.
• Ensures inspection readiness of global ICSR & Literature procedures.
• Works extensively with Team Lead, Literature Management & Global Governance, other RAPV and non-RAPV stakeholders as well as selected vendor personnel, to identify opportunities for improvement and ensures that ICSR & Literature procedures directly support the ongoing assurance of the safety profile of Astellas products.

Responsibilities And Accountabilities
Processes and procedures, particularly related to ICSR processing

• Continuously assess all global ICSR & Literature related processes and identify opportunities to improve efficiency, effectiveness and compliance
• Coordinate the implementation of process improvements, manage planned and unplanned deviations and ensure accurate periodic review
• Lead process improvement initiatives and projects as required
• Maintain oversight of global and regional/local procedures to ensure no duplication, discrepancy, conflict or gap exists between procedures
• Ensure timely and global decision making regarding global procedures, taking into consideration regional requirements
• Responsible for setting standards, decision making, and maintenance of case handling conventions and other reference materials in consultation with RAPV stakeholders
• Liaise with PV-Technology & Transformation for LSMV system changes to ensure accurate and timely assessment of impact to procedural documents, trainings and reference materials.
• In consultation with the Case Management Lead, be liaison with Medical Safety and Safety Science & Labelling for impact of process changes on their activities
• Provide industry experience
• Coordinate the impact analysis for global regulatory intelligence results for ICSR & Literature procedures.

Training

• Coordinate and oversee the development of training materials for ICSR & Literature related procedures
• Responsible for maintenance of training matrix and coordination of training delivery for RAPV Operations staff (in collaboration with Quality Management Systems function)
• Maintain the contents of PV awareness training in line with global AE collection standards and requirements.

Required Qualifications

• Minimum MSc in life sciences
• Minimum of 7 years relevant experience in pharmacovigilance or combined PV/RA/QA, and/or clinical development
• Strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration.
• Excellent oral and written communication skills in English, with an ability to interact with all levels of personnel
• Demonstrated ability to proactively predict and resolve complex problems, think strategically and tactically, generate solutions to complex problems and build consensus across the global organization.
• Able to generate insights and leverage learnings at the individual, team and functional level.
• Excellent communication and presentation skills in English (written and spoken), and able to lead meetings, present orally and interact with external bodies. Experience with global responsibilities for procedure maintenance and safety process improvement projects
• Able to interpret, execute and recommends changes to established policies and programs
• Able to determine best course of action based on strategic direction
• Strong leadership skills
• Decision making skills
• Negotiation skills
• Independent worker – plans, schedules and arranges own activities to achieve desired results
• Independently manages projects that span across various functions or departments
• Strong analytical skills
• Extensive PV knowledge
• Demonstrated experience in a governance role
• Six sigma or similar process improvement methodology knowledge is a plus

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

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

EOE including Disability/Protected Veterans