Director, Medical Safety- Sponsor-Dedicated (Home-based)
Core
Lead global medical safety and pharmacovigilance oversight for clinical and post-marketing programs, conducting medical reviews of safety data and regulatory reports.
Role type
Director, Medical Safety (Sponsor-Dedicated)
Builds
Safety documentation, regulatory submissions, risk management plans, and benefit-risk assessments for pharmaceutical clients.
Domain
Life Sciences / Pharmacovigilance / Clinical Research
Required skills
Global pharmacovigilance, clinical research, safety reporting, GCP, regulatory requirements, clinical development, pharmaceutical research, medical safety monitoring, people management, project oversight, financial accountability, strategic decision-making, consulting, communication, stakeholder management, relationship-building
Preferred skills
None stated
Technologies
None stated
Responsibilities
Conduct medical review of clinical trial and post-marketing safety data; Provide medical oversight and review of safety documentation; Support safety governance activities; Serve as Global Safety Physician, project lead, or medical safety advisor; Present safety findings and provide expert medical consultation; Lead and develop medical safety teams; Oversee financial, operational, and quality performance of assigned projects; Contribute to business development activities; Represent the Medical Safety function internally and externally; Drive continuous improvement through awareness of industry, regulatory, and pharmacovigilance developments; Lead medical review of safety data, regulatory reports, risk management strategies, and benefit-risk assessments; Manage medical safety projects; Lead, develop, and resource teams of physicians and medical safety professionals globally; Support business growth through client engagement, proposals, strategic initiatives, and service-line leadership
Seniority
Director, strategic leadership & people management