Global Safety Senior Director, PV Scientist at Jobgether – United States

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Global Safety Senior Director, PV Scientist in the United States.

We are seeking a Global Safety Senior Director to provide strategic leadership in pharmacovigilance and patient safety across an international portfolio of medicines. This role oversees all major safety submissions, benefit-risk evaluations, and risk management activities, ensuring regulatory compliance and scientific rigor. You will guide cross-functional teams, mentor safety professionals, and act as a key decision-maker in governance processes. The position involves direct interaction with global regulatory agencies, oversight of safety data interpretation, and participation in advisory committees. The ideal candidate combines scientific expertise with operational leadership to influence product safety strategy, drive process improvements, and safeguard patient outcomes in a complex, high-impact environment.

• Develop and execute global safety strategy, including pharmacovigilance plans, benefit-risk evaluations, and risk management plans.
• Lead preparation, review, and approval of safety sections in regulatory submissions, periodic reports (PSUR/PBRER, DSUR), and Investigator’s Brochures.
• Monitor and interpret safety data from clinical studies and real-world evidence, contributing to core safety messages and regulatory decision-making.
• Represent the safety function in governance meetings, advisory committees, and cross-functional teams, ensuring alignment on risk mitigation strategies.
• Oversee day-to-day activities of Global Safety Officers and Physicians, ensuring adherence to SOPs, training, and corporate safety policies.
• Develop and mentor the safety team, fostering professional growth, technical excellence, and collaborative culture.
• Manage responses to regulatory agency inquiries and inspection readiness within the scope of safety responsibilities.

Requirements:

• Doctorate degree with 5+ years of global safety experience, or Master’s degree with 9+ years, or Bachelor’s degree with 11+ years.
• At least 5 years of leadership experience managing teams, projects, or programs in drug safety or pharmacovigilance.
• Clinical or scientific experience preferred (MD, DO, or PhD), with familiarity in obesity or cardiometabolic conditions advantageous.
• Strong knowledge of regulatory safety requirements, including NDA submissions, RMPs, PSURs, PBRERs, DSURs, and DILs.
• Experience in benefit-risk assessment, signal detection, safety data analysis, and global regulatory interactions.
• Excellent communication, mentoring, and cross-functional collaboration skills.
• Hands-on and strategic thinker capable of leading complex safety programs in a dynamic, international environment.

Benefits:

• Competitive annual salary range ($229,628 – $274,119) with potential for performance-based bonuses.
• Comprehensive medical, dental, and vision coverage.
• Retirement and savings plans with employer contributions.
• Flexible time-off policies and paid holidays.
• Professional development, training, and mentorship opportunities.
• Participation in a collaborative, science-driven culture with flexible work options where applicable.