Associate Director/Director, Pharmacovigilance Scientist Team Leader, Global Patient Safety
lilly · Cork
Job description
About the role
The Global Patient Safety (GPS) organization delivers scientific, medical and pharmacovigilance expertise for Lilly's products in development and for marketed medicines and devices worldwide. The Pharmacovigilance Scientist Team Leader provides strategic leadership and operational oversight of a team of Pharmacovigilance Scientists, covering signal detection and management, safety data evaluation, benefit-risk assessment, regulatory compliance and periodic reporting. The role combines advanced technical expertise with people leadership.
Key responsibilities
- Supervise and lead a team of Pharmacovigilance Scientists, including workload management, performance evaluation, coaching, recruitment, onboarding and training, and performance reviews
- Ensure systematic detection, validation and evaluation of safety signals and guide product-specific safety surveillance plans with GPS Medical colleagues
- Define data acquisition strategies for safety evaluations and act as escalation point for complex safety data analysis
- Develop and maintain risk assessments across the product lifecycle and coach cross-functional safety communications, including labeling and clinical documents
- Oversee periodic safety reports (DSURs, PADERs/PAERs, PSURs, PBRERs), health authority queries and regulatory submissions, and ensure compliance with ICH, FDA, EMA and other guidelines
- Act as subject matter expert during health authority inspections and audits, and track deliverable timelines
- Drive continuous improvement, departmental strategy and policy, and represent GPS in cross-functional forums
- Support the Qualified Person in meeting their legal responsibilities and comply with Lilly Red Book and corporate integrity requirements
Required profile
- Advanced medical-related graduate degree (e.g. PharmD, nursing with advanced clinical specialty, PhD with 1-3 years' experience in a related scientific field)
- OR BS degree in a health-related or scientific field with 7-10 years of experience in the pharmaceutical industry, with relevant clinical trial, drug discovery or development experience
- Preferred: clinical knowledge of disease states and pharmacology, supervisory experience, strong knowledge of patient safety regulations, and ability to manage multiple deliverables
What we offer
- Anticipated wage of EUR 78,750 - 115,500
- Possible company bonus for full-time equivalent employees depending on performance
- Benefits including pension plan, vacation, healthcare, flexible benefits, life insurance, time off and leave of absence, and well-being benefits
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Published 2 hours ago
Expires 1 month from now
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lilly
Cork
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