Global Clinical Safety Executive Director

i-Pharm Consulting; Philadelphia (Philadelphia County); On-site; USD 260,000 - 360,000; Full time

Job summary

i-Pharm Consulting seeks a Senior/Executive Director of Global Clinical Safety to lead safety programs across development and post-marketing. This role provides strategic and medical oversight, driving signal detection, benefit–risk assessment, and global safety strategy.

In a fast-paced, collaborative environment, you will influence regulatory strategy and safety governance at a global level, partnering with cross-functional teams to ensure inspection readiness and regulatory compliance.

Qualifications

• MD required with clinical safety/pharmacovigilance expertise.
• 12+ years in clinical safety/pharmacovigilance within biotech/pharma.
• Experience with signal detection, safety surveillance, and benefit–risk assessment.
• Knowledge of global safety regulations and reporting requirements.
• Ability to operate in a matrixed, cross-functional environment.
• Experience contributing to regulatory filings and health authority interactions.
• Demonstrated leadership and stakeholder management.

Responsibilities

• Serve as the medical and scientific expert for safety across assigned programs (early through late-stage and/or marketed products).
• Lead signal detection, evaluation, and risk management activities, including interpretation of safety data from multiple sources.
• Drive benefit–risk assessments and contribute to safety governance forums.
• Author and/or review regulatory safety documents (e.g., DSURs, PBRERs, IBs, safety sections of submissions).
• Partner cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, and PV Operations to align on safety strategy.
• Support global regulatory interactions, including responses to health authority queries.
• Ensure inspection readiness and compliance with global pharmacovigilance regulations (FDA, EMA, ICH, etc.).
• Contribute to the development and scaling of safety processes, infrastructure, and best practices.

Skills

Clinical safety

Pharmacovigilance

Leadership

Regulatory strategy

Education

MD (or equivalent)

Job description

i-Pharm Consulting seeks a Senior/Executive Director of Global Clinical Safety to lead safety programs across development and post-marketing. This role provides strategic and medical oversight, driving signal detection, benefit–risk assessment, and global safety strategy.

In a fast-paced, collaborative environment, you will influence regulatory strategy and safety governance at a global level, partnering with cross-functional teams to ensure inspection readiness and regulatory compliance.