Associate Director, Pharmacovigilance Operations ICSR Management

GlaxoSmithKline - Durham, NC

Full-time - Mid Level

Hybrid - Durham, NC

5,001-10,000 employees

Chemical Manufacturing

About the position

The Associate Director, Pharmacovigilance Operations - ICSR Management is responsible for overseeing vendor case processing and ensuring compliance with GSK processes. This role involves managing the ICSR Management team, conducting investigations into non-compliance, and providing strategic advice to enhance pharmacovigilance operations. The position requires collaboration with various stakeholders to ensure effective safety data management throughout clinical trials and post-marketing programs.

Responsibilities

• Oversee vendor case processing and related activities, ensuring compliance with GSK processes.
• Manage the GSK ICSR Management team and ensure appropriate resourcing for all ICSR management activities.
• Conduct investigations into non-compliance and perform gap analysis.
• Critically analyze data and metrics produced by the vendor.
• Collaborate with stakeholders to ensure successful recording and reporting of safety data during clinical trials and marketed products.
• Drive high-quality delivery of case management activities that comply with internal and external regulatory requirements.
• Supervise scientific staff supporting ICSR Management activities.
• Provide project management and case processing oversight for clinical trials and post-marketed programs.

Requirements

• Degree in life sciences or a medically related field or equivalent experience.
• Case processing experience in clinical trials and post-marketing.
• Experience in quality processes for pharmacovigilance, including compliance metrics and writing quality issue reports.
• Experience in performing trend analysis and gap analysis.
• SOP writing experience.
• Knowledge and experience with pharmacovigilance systems.

Nice-to-haves

• Proven experience developing and delivering high-quality training.
• Proven experience in line management.
• Experience with escalation mechanisms.

Benefits

• Competitive salary
• Annual bonus based on company performance
• Healthcare and wellbeing programmes
• Pension plan membership
• Shares and savings programme
• Hybrid working model through Performance with Choice programme