Job Title: ICSR & Literature Procedure Management Professional
Company: Astellas
Location: Bengaluru, India
Job Type: Full-time
Reports to: Team Lead, Literature Management & Global Governance
Travel: Not specified
Responsible for ICSR & Literature Procedure Management, ensuring up-to-date global processes, best practices, training, and continuous process improvement.
Supports the successful execution of PV Case Management objectives and 1–3 year operational plans, contributing to the RAPV mission.
Maintains global consistency of ICSR & Literature procedures and training programs.
Collaborates with global and regional stakeholders to develop cross-functional procedures.
Ensures inspection readiness of global ICSR & Literature procedures.
Works closely with Team Lead, Literature Management & Global Governance, RAPV and non-RAPV stakeholders, and selected vendors to improve processes that support the safety profile of Astellas products.
1. Process & Procedure Management:
Continuously assess global ICSR & Literature processes for efficiency, effectiveness, and compliance.
Coordinate implementation of process improvements, manage deviations, and ensure timely periodic reviews.
Lead process improvement initiatives and projects.
Maintain oversight of global and regional/local procedures to avoid duplication, discrepancies, or gaps.
Ensure timely and consistent global decision-making on procedural changes considering regional requirements.
Set standards and maintain case handling conventions and reference materials in consultation with RAPV stakeholders.
Liaise with PV-Technology & Transformation for system changes (LSMV) impacting procedures, trainings, and reference materials.
Consult with Case Management Lead, Medical Safety, and Safety Science & Labeling on process change impacts.
Coordinate impact analysis for global regulatory intelligence results relevant to ICSR & Literature.
2. Training & Development:
Coordinate and oversee development of training materials for ICSR & Literature procedures.
Maintain training matrix and coordinate training delivery for RAPV Operations staff in collaboration with Quality Management Systems.
Update PV awareness training content to align with global AE collection standards and requirements.
MSc in Life Sciences (minimum).
Minimum 7 years relevant experience in pharmacovigilance, combined PV/RA/QA, and/or clinical development.
Strong interpersonal skills, multi-cultural awareness, negotiation, and consensus-building abilities.
Excellent oral and written communication skills in English; ability to interact at all organizational levels.
Proven ability to predict and resolve complex problems, think strategically and tactically, and build consensus globally.
Strong analytical skills and extensive PV knowledge.
Demonstrated leadership, decision-making, and project management skills.
Experience in governance roles, procedure maintenance, and safety process improvement projects.
Six Sigma or similar process improvement methodology knowledge is a plus.
Astellas’ Global Capability Centres (GCCs) in India, Poland, and Mexico.
GCCs enable operational efficiency, resilience, and innovation by co-locating core capabilities.
GCCs support timely response to business needs and are integral to Astellas’ strategic priorities, sustainable growth, and mission to deliver value for patients.
Pharmacovigilance / Safety & Literature Management
Astellas is an equal opportunity employer (EOE), including Disability/Protected Veterans.
Committed to equality of opportunity in all aspects of employment.
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