Position: PV Data Assurance Professional
Job ID: 1759
Location: Bengaluru, India
Astellas is a global pharmaceutical company committed to excellence in pharmacovigilance (PV) and case management. The company focuses on ensuring operational efficiency, data quality, and compliance with global standards across ICSRs and literature case management.
Responsible for the development and maintenance of excellence in Data Assurance within PV Case Management. Focus on operational aspects of ICSRs and literature, ensuring quality, consistency, and efficiency across regions and case processing vendors.
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 case narratives)
Unblinding
Quality control and monitoring performed by vendors.
Manage incoming safety information from co-licensors, partners, affiliates, and third parties.
2. Quality, Data Assurance, Training & Business Information Management
Represent PV Case Management in inspections, audits (PV, GMP, GCP) as a subject matter expert.
Justify Astellas’ case assessment decisions to external authorities.
Review and monitor key compliance and quality metrics to drive continuous quality improvement.
3. Capacity Management, Oversight & Budget
Support global case flow capacity management through accurate forecasting for developmental and post-marketing activities.
Ensure business continuity and resource planning adaptation.
Assist in evaluation, selection, onboarding/training of outsourced resources and issue escalation.
4. Regional Knowledge & Accountability
Maintain awareness of regulatory requirements in key regions (USA, EU/EEA).
Keep up-to-date with all regulatory guidelines for intake, review, and reporting of safety information.
5. People & Organization Management
Implement organizational structures that optimize resource use globally.
Manage recruitment, performance, development planning, and retention of high-performing PV Case Management teams.
6. Strategy Development and Execution
Lead PV Data Assurance regional team to support global policies and standards.
Implement PV Case Management operational support tools to ensure quality and consistency.
7. Training
Train and educate Vendor and PV Case Management staff.
Represent PV in cross-functional training sessions promoting PV awareness.
Provide specialist education to PV and non-PV staff.
Conduct PV Case Management overviews for new employees in Data Assurance.
Education: Minimum BA/BS; advanced professional degree preferred.
Experience:
Minimum 5 years in PV or combined PV/RA/QA/clinical development.
Leadership experience managing global, multidisciplinary teams.
Knowledge:
Safety regulations for marketed and investigational products.
Global health authority requirements (ICH, CFR 21, FDAAA, EU GVP, JP regulations).
ICSR processing regulatory requirements for assigned region.
Process management, standards, and training across the product lifecycle.
Skills:
Establishing and maintaining GxP Quality Management Systems.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Argentina | Peru |Brazil :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Kyiv |Lima Region :
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Paris | Lyon |South Africa :
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