Job Title: PV Data Assurance Professional
Company: Astellas
Location: Bengaluru, India
Job Type: Full-time
Reports to: PV Operations/Case Management Leadership
Travel: Not specified
Purpose & Scope:
Responsible for the development and maintenance of excellence in Data Assurance, focusing on operational aspects of Individual Case Safety Report (ICSR) and literature global standards. Drives quality, consistency, and operational efficiency across Astellas PV Case Management functions, regions, and case processing vendors.
Key Responsibilities:
1. ICSR and Safety Information Processing:
Implement global ICSR case processing policies and strategies.
Create and maintain conventions, tools, and processes for non-medical review and assessment of ICSRs and literature, including:
Case intake
Data entry (including narratives)
Unblinding
Quality control and monitoring (performed by vendor if applicable)
Manage incoming safety information from co-licensors, partners, affiliates, and third-party sources.
2. Quality, Data Assurance, Training & Business Information Management:
Represent PV Case Management team in inspections, PV audits, and non-PV audits (GMP/GCP) as SME on case quality.
Justify Astellas’ opinion regarding individual case assessments to external bodies.
Support review of compliance and quality metrics to drive continuous improvement in-house and with vendors.
3. Capacity Management & Oversight, Budget:
Support capacity management of global case flow via accurate forecasting.
Ensure business continuity through resource planning.
Participate in evaluation, onboarding, training, issue resolution, and escalation of outsourced resources.
4. Regional Knowledge & Accountability:
Maintain continuous awareness of regional regulations and guidelines (USA, EU/EEA, etc.).
Stay updated on all regulatory requirements for intake, collation, assessment, and reporting of safety information.
5. People & Organizational Management:
Implement optimal organizational structures considering global impact.
Recruit, manage performance, develop, and retain high-performing PV Case Management teams.
Promote a matrix environment for efficient PV operations.
6. Strategy Development & Execution:
Lead and oversee PV Data Assurance regional team to support global policies and standards.
Implement operational support tools to ensure quality and consistency.
7. Training:
Train and provide specialist education for vendor and PV Case Management staff.
Represent PV in cross-functional training sessions.
Provide PV awareness and education to internal and external staff, including new employees.
Required Qualifications:
Minimum BA/BS; advanced professional degree preferred.
Minimum 5 years of relevant experience in pharmacovigilance, PV/RA/QA, or clinical development.
Extensive leadership experience, including managing global multidisciplinary teams.
In-depth understanding of safety regulations for marketed and investigational products.
Excellent knowledge of global health authority requirements (ICH, CFR 21, FDAAA, EU GVP modules, JP regulations).
Strong understanding of ICSR processing regulatory requirements and guidelines.
Proven experience establishing and maintaining (GxP) Quality Management Systems.
Expertise in process management, standards, and training across pharmaceutical product life cycle.
Company Commitment:
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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