Global Clinical Safety Executive (MD) – Strategy & Regulation

i-Pharm Consulting; Philadelphia (Philadelphia County); Hybrid; USD 250,000 - 360,000; Full time

Job summary

i-Pharm Consulting is seeking a Senior/Executive Director of Global Clinical Safety to lead safety strategy across clinical development and post-marketing programs. This role will oversee signal detection, risk management, and global safety governance with regulatory interactions.

The successful candidate will bring MD (or equivalent) credentials and 12–18+ years in safety/pharmacovigilance, with strong matrixed leadership experience and industry regulatory knowledge.

Qualifications

• MD (or equivalent) required.
• 12–18+ years of clinical safety/pharmacovigilance experience.
• Deep expertise in signal detection, safety surveillance, and benefit–risk assessment.
• Strong understanding of global safety regulations and reporting requirements.
• Proven ability to operate in a matrixed, cross-functional environment.
• Experience contributing to regulatory filings and health authority interactions.

Responsibilities

• Serve as the medical and scientific expert for safety across assigned programs.
• Lead signal detection, evaluation, and risk management activities.
• Drive benefit–risk assessments and contribute to safety governance forums.
• Author and/or review regulatory safety documents (DSURs, PBRERs, IBs).
• Partner with Clinical Development, Regulatory Affairs, Biostatistics, and PV Operations.
• Support global regulatory interactions and responses to health authority queries.
• Ensure inspection readiness and compliance with global pharmacovigilance regulations.
• Contribute to the development and scaling of safety processes and best practices.

Skills

Clinical safety/pharmacovigilance

Signal detection

Safety surveillance

Global safety regulations

Leadership

Regulatory filings

Education

MD (or equivalent)

Job description

i-Pharm Consulting is seeking a Senior/Executive Director of Global Clinical Safety to lead safety strategy across clinical development and post-marketing programs. This role will oversee signal detection, risk management, and global safety governance with regulatory interactions.

The successful candidate will bring MD (or equivalent) credentials and 12–18+ years in safety/pharmacovigilance, with strong matrixed leadership experience and industry regulatory knowledge.