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Astellas is inviting applications for the role of PV Data Assurance Professional in Bengaluru. This is an excellent opportunity for experienced pharmacovigilance professionals skilled in ICSR quality, PV operations, case management oversight, and global safety compliance.
If you are looking to advance your PV career with a global pharmaceutical leader, this opening is designed for you.
🔍 Job Responsibilities
ICSR & Safety Information Processing
- Implement global ICSR case processing policies and operational strategies.
- Develop tools and conventions for non-medical review of ICSRs and literature.
- Manage intake, data entry, narrative quality, unblinding, QC, and vendor monitoring.
- Oversee safety information received from partners, affiliates, and third parties.
Quality, Data Assurance & Training
- Act as SME during PV, GMP, GCP audits and inspections.
- Defend Astellas’ stance on case assessments to regulatory authorities.
- Review compliance metrics and drive outsourced & in-house quality improvements.
- Support training for vendor teams and PV case management staff.
Capacity Management & Vendor Oversight
- Support global case flow forecasting and resource planning.
- Assist in vendor evaluation, onboarding, training, and issue resolution.
Regulatory Intelligence & Regional Accountability
- Maintain strong awareness of regional PV regulations (US, EU/EEA, Japan).
- Track updates to global safety reporting requirements and guidelines.
People & Organizational Management
- Support team structure optimization and resource utilization.
- Manage recruitment, performance, development, and retention.
- Foster a collaborative and high-performance PV environment.
Strategy & Execution
- Lead regional PV Data Assurance team to ensure operational consistency.
- Implement PV Case Management operational tools globally.
📌 Required Qualifications
- Bachelor’s degree (BA/BS minimum; advanced degree preferred).
- 5+ years of experience in PV, Regulatory Affairs, QA, or clinical development.
- Strong leadership experience managing global, cross-functional teams.
- Deep knowledge of global PV regulations (ICH, CFR 21, FDAAA, EU GVP, JP).
- Expertise in ICSR processing standards and regional regulatory requirements.
- Hands-on experience with GxP Quality Management Systems.
- Strong process management, training, and documentation skills.
💼 Benefits
(Typical benefits offered in global pharma roles—adjust as needed)
- Competitive salary and performance incentives
- Global exposure and cross-functional leadership opportunities
- Learning & development programs
- Inclusive, diverse work culture
- Career advancement within a global PV organization
📨 How to Apply
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