Director, Safety Scientist

Role Summary

Director, Safety Scientist responsible for leading safety signal detection, data evaluation, regulatory responses, and safety reporting for assigned compounds, in collaboration with Product Safety Leads and cross-functional teams. Provides medical safety assessment and communicates effectively with internal and external stakeholders to comply with global regulations.

Responsibilities

• Signal and Safety Data Evaluation: identify, analyze, and evaluate safety signals from multiple data sources; define data acquisition strategy; perform safety data analysis and author safety assessments; collaborate with cross-functional teams to ensure thorough evaluation; lead signal assessment and safety governance discussions; develop safety communication documents; document signal assessments according to governance framework.
• Clinical Trial Support: review safety data and monitor patient safety in trials; author and review safety sections for Protocols, IBs, ICFs, SAPs, TFLs, MMPs, CSRs, and regulatory responses; prepare safety sections for regulatory submissions; create Storyboards and Briefing Books for health authority interactions; train investigators in Safety Science; conduct risk assessments and periodic reporting.
• Health Hazard Evaluations: contribute to integrated Benefit/Risk assessments.
• Promote and Advance Pharmacovigilance: coordinate with internal and external stakeholders; support employee development and Safety Science training; identify improvements to organizational effectiveness; ensure compliance with quality systems and regulations.
• Other duties as assigned by manager to support departmental activities.

Qualifications

• Education: PharmD, NP, RN, or PhD in a medical field or biological science with 8+ years as a Safety Scientist; or MD with relevant clinical training and 6+ years in Safety Science/Clinical Development with 4+ years clinical experience preferred.
• Experience: pharmaceutical/biotechnology industry experience in pharmacovigilance, clinical development, or clinical research; prior matrix management experience; experience with regulatory agency interactions.
• Regulatory: familiarity with global regulatory requirements for pharmacovigilance; experience preparing safety sections for IND/CTA, NDA/MAA, and regulatory responses.

Skills

• Advanced proficiency with safety databases (e.g., Argus), MedDRA, signal management systems, data mining tools (Spotfire, PowerBI); advanced MS Office and electronic document management systems (e.g., Veeva).
• Strong leadership, communication, and presentation skills; ability to lead safety meetings and influence stakeholders; in-depth scientific and clinical judgment; ability to prioritize multiple deliverables.

Education

• PharmD, NP, RN, or PhD in medical or biological science with 8+ years in Safety Science; or MD with 4+ years clinical experience plus 6+ years in Safety Science/Clinical Development (preferred).

Additional Requirements

• Travel: Less than 10%