- Lead daily operational execution and oversight of Global Case Receipt activities
- Ensure timely, accurate, and compliant execution of case receipt
- Manage team capacity, resource needs, workload allocation, and staffing priorities
- Provide people leadership, including training oversight, development planning, and performance support
- Develop, monitor, and report operational metrics and key performance indicators
- Partner with internal GMSO functions and other stakeholders to clarify procedures and resolve issues
- Identify and lead process improvement initiatives and cross-functional projects
- Support audit, inspection, and quality readiness
- Lead or support investigations, risk assessments, nonconformance reviews, CAPA activities, and remediation plans
Requirements
- Bachelor’s degree in a health‑related or scientific discipline is required
- Advanced degree (PhD, PharmD) preferred
- Active professional licensure/certification required for nurses or pharmacists (e.g., RN, RPh, PharmD)
- Minimum of 8+ years of pharmaceutical industry or clinical experience with a focus on pharmacovigilance and drug safety, including individual case management
- Demonstrated knowledge of global safety reporting regulations and guidelines and regulatory compliance across the product lifecycle
- Experience working in a high‑volume, regulated operational environment preferred
- Proficiency with standard office applications; familiarity with pharmacovigilance safety systems required (ArigGlobal LSMV preferred)
Core Competencies
Demonstrates expertise in leading operational execution within the pharmaceutical industry, focusing on case receipt activities, regulatory compliance, and process improvement. Proficient in managing team dynamics and performance while ensuring adherence to global safety reporting regulations.
Highest-signal resume keywords
- Pharmaceutical Industry Experience
- Pharmacovigilance Knowledge
- Regulatory Compliance Expertise
- Team Leadership and Development
- Process Improvement Initiatives
ATS Optimization Keywords
Hard Skills
- Case Management
- Operational Metrics Development
- Key Performance Indicators Monitoring
- Risk Assessment
- Nonconformance Review
- CAPA Activities
- Audit Support
- Inspection Readiness
- Quality Readiness
Soft Skills
- People Leadership
- Training Oversight
- Performance Support
- Collaboration
Certifications & Qualifications
Industry Keywords
- Global Case Receipt
- Drug Safety
- Health-Related Discipline
- Scientific Discipline
- High-Volume Operational Environment
Tools & Technologies
- Pharmacovigilance Safety Systems
- ArigGlobal LSMV
- Standard Office Applications