USA - Associate Director Global Regulatory Affairs (CMC)

About the role

The Fountain Group is seeking an Associate Director, Signal Management and Innovation for a prominent client. This is a remote position responsible for leading global pharmacovigilance signal detection and management processes, ensuring compliance with health authority requirements, acting as a subject matter expert, collaborating with cross‑functional teams, overseeing vendor activities, and mentoring junior staff.

Responsibilities

• Lead development, maintenance, and continuous improvement of global pharmacovigilance signal detection and management processes.
• Ensure signal management activities align with global Health Authority requirements, including EU regulations and regulatory inspection expectations.
• Serve as a global subject matter expert for signal detection and management within Pharmacovigilance.
• Partner with Global Regulatory Affairs, Data Sciences, Global Medical Safety, EU QPPV, and other PSPV stakeholders to maintain compliant and fit‑for‑purpose processes.
• Provide oversight of signal management activities performed by external vendors.
• Represent Pharmacovigilance in global and regional cross‑functional committees and external regulatory engagements.
• Develop and deliver training related to signal detection and management processes.
• Mentor junior Pharmacovigilance scientists and support designated process improvement projects.

Requirements

Education: Bachelor's degree in Life Sciences, Healthcare, Pharmacy, Medicine, or a related discipline required. Advanced degree in Life Sciences or a related scientific discipline preferred.

Required Skills:

• Pharmacovigilance and Medical Safety Sciences
• Signal detection and signal management
• Pharmacovigilance regulations and Health Authority requirements
• EU pharmacovigilance regulations and regulatory inspection expectations
• Clinical trial methodology
• Risk‑benefit assessment and analysis
• Safety data review, analysis, interpretation, and presentation
• Development and maintenance of pharmacovigilance processes and procedures
• Cross‑functional collaboration with Data Sciences and Regulatory Affairs
• Vendor oversight for signal management activities
• Pharmacovigilance process training and documentation

Qualifications

Preferred Skills:

• Global signal management experience within a pharmaceutical or biotechnology organization
• Experience supporting EU regulatory requirements and inspections
• Experience developing or improving signal detection methodologies and processes
• Experience representing Pharmacovigilance as a subject matter expert in global or regional forums
• Experience mentoring Pharmacovigilance scientists
• Experience leading process‑related projects within Patient Safety/PV organizations

Pay

Pay Rate: $117.59‑$113.67