SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Salary: USD 110,700 - 166,100 / annual
Precision for Medicine seeks an experienced Safety Lead to oversee pharmacovigilance and clinical safety operations for clinical trial projects. This role combines subject-matter expertise with team leadership and project management responsibilities.
Key responsibilities include: leading serious adverse event (SAE) case management from intake through regulatory reporting; developing and implementing safety management plans and standard operating procedures; overseeing safety database design and SAE data capture; preparing and reviewing safety reports, training materials, and regulatory submissions; providing mentorship and training to Safety Specialists; managing safety budgets and resource allocation; serving as departmental subject-matter expert; leading cross-functional safety initiatives; supporting regulatory inspections and audit preparation; and assisting with client bid defenses and safety-related consulting.
You will interface regularly with sponsors, vendors, internal teams, and study site personnel to design and implement safety collection tools, processes, and reporting systems. The role requires hands-on expertise with global safety databases, medical coding (MedDRA, WHODrug), and deep knowledge of FDA regulations, ICH guidelines, and global regulatory requirements for clinical trials.
Minimum qualifications: BA/BS degree, 10+ years clinical safety experience, 5+ years pharmacovigilance experience, and healthcare professional credentials. Preferred: nursing or pharmacy degree, CRO or pharmaceutical company experience, and project management background. You must demonstrate excellent communication, analytical judgment, and the ability to translate complex clinical issues into clear, scientifically sound guidance for diverse audiences.
