Global PV Operations, ICSR Management Director

GlaxoSmithKline - Philadelphia, PA

Full-time - Senior

Philadelphia, PA

Chemical Manufacturing

About the position

The Global PV Operations, ICSR Management Director at GSK is responsible for overseeing the management of Individual Case Safety Reports (ICSRs) and ensuring compliance with regulatory requirements. This role involves leadership in case management, vendor oversight, and collaboration with local operating companies to maintain high standards in pharmacovigilance operations. The director will also be involved in the setup and configuration of safety databases for new programs and studies, ensuring efficient processes and timely reporting of human safety information.

Responsibilities

• Provide leadership for the ICSR Management Team to achieve group objectives.
• Oversee outsourcing partners who process over 300,000 cases annually in the GSK global safety database.
• Ensure compliance with regulatory requirements and establish management monitoring activities.
• Deliver efficient, compliant processes and address deficiencies in ICSR management.
• Prepare for and implement corrective actions for audits and inspections.
• Facilitate cross-functional collaboration within Global Safety for timely processing of Human Safety Information.
• Establish and maintain key performance indicators for case management operations.

Requirements

• Bachelor's degree in a scientific or medically related field (e.g., Nurse or pharmacist).
• Experience in the pharmaceutical industry/CRO in clinical development, pharmacovigilance, and information management.
• Previous line management experience.

Nice-to-haves

• Extensive clinical safety or related experience (10+ years).
• Significant history of management experience.
• Demonstrated experience effectively working with outsourced providers.
• High level of clinical understanding.
• Excellent oral and written communication skills.
• In-depth knowledge of ICH, GCP, GVP, CTR, and local regulatory requirements.
• Proven ability to negotiate and influence stakeholders at upper management levels.
• Deep knowledge of principles of data collection, analysis, and retrieval.

Benefits

• Competitive salary
• Opportunities for professional development
• Flexible working arrangements
• Health and wellness programs
• Diversity and inclusion initiatives