Senior Director of Drug Safety - Remote

Overview

The Senior Director of Drug Safety will manage all aspects of drug safety functions related to postmarketing surveillance, ensuring compliance and strategic partnerships while collaborating with various departments.

In Short

• Manage drug safety relationships with partners and vendors.
• Oversee postmarket pharmacovigilance systems.
• Develop assessments of global safety data.
• Ensure compliance with safety data exchange agreements.
• Act as a liaison for safety signal management.
• Support safety review meetings with stakeholders.
• Prepare reports for management and regulatory agencies.
• Implement pharmacovigilance SOPs.
• Collaborate with other BridgeBio affiliates on projects.
• Travel as required.

Requirements

• Bachelor’s degree in a health care discipline; advanced degree preferred.
• 12+ years of drug safety and pharmacovigilance experience.
• Experience with FDA and international regulatory authorities.
• Management experience in drug safety or CSO.
• Knowledge of GCP and FDA regulations.
• Experience in clinical trial and post-marketing safety.
• Strong communication and collaboration skills.
• Ability to manage compliance deviations.
• Experience with safety signal management systems.
• Familiarity with safety databases and reporting tools.

Benefits

• Patient Days to hear from individuals impacted by conditions.
• A culture focused on patient-first values.
• Decentralized model for decision-making.
• Opportunities for career advancement.
• Access to learning and development resources.
• Market-competitive compensation and benefits package.
• Flexible PTO.
• Commitment to Diversity, Equity & Inclusion.