Vice President, Drug Safety and Pharmacovigilance

The role

The Vice President of Drug Safety and Pharmacovigilance will provide strategic leadership and medical oversight for all pharmacovigilance and drug safety activities. This person will establish global safety strategy, governance, and risk-management capabilities across a clinical-stage portfolio.

What you will do

• Develop and lead global pharmacovigilance and drug safety strategy.
• Serve as the senior medical authority for safety matters and benefit-risk assessments.
• Lead safety surveillance and signal detection.
• Establish and lead Safety Review Committees and safety-governance forums.
• Oversee preparation and medical review of aggregate safety reports.
• Provide safety input into clinical protocols, Investigator’s Brochures, and regulatory submissions.
• Lead strategy and preparation for responses to regulatory authority inquiries.
• Represent Drug Safety and Pharmacovigilance during interactions with global regulatory authorities.
• Build and maintain pharmacovigilance policies, procedures, and reporting infrastructure.
• Oversee individual case safety report processing and safety database operations.

Required qualifications

• MD or equivalent medical degree
• Minimum of 12 years of progressive experience in pharmacovigilance, drug safety, clinical development, or a closely related function within the biotechnology, pharmaceutical, or CRO industry.
• Significant leadership experience including responsibility for pharmacovigilance strategy, teams, governance, and outsourced operations.
• Demonstrated experience building or scaling a pharmacovigilance function within a clinical-stage biotechnology or pharmaceutical company.
• Deep knowledge of global pharmacovigilance regulations and guidance, including pre- and post-marketing safety requirements in the United States and European Union.
• Demonstrated expertise in safety surveillance, signal management, aggregate reporting, risk management, and benefit-risk assessment.
• Strong experience supporting clinical development programs and regulatory submissions.
• Proven experience leading regulatory authority interactions and supporting successful pharmacovigilance inspections.
• Experience overseeing CROs, pharmacovigilance service providers, safety databases, and other outsourced operations.
• Exceptional medical judgment, analytical thinking, scientific writing, and executive communication skills.
• Ability to lead effectively in a fast-paced, growing organization.

Nice to have

• Board certification or relevant postgraduate clinical training
• Experience in a biotechnology or start-up environment
• Experience with RNA therapeutics or therapeutic areas relevant to City Therapeutics’ pipeline

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package

Before you apply

• City Therapeutics is accepting resumes/CVs from direct applicants only.
• Recruitment Agency submissions will not be accepted at this time.

About the company

City Therapeutics is engineering the future of RNAi-based medicine. They are building a diversified research and development pipeline to create best-in-class medicines.