Director, Safety Scientist

Role Summary

Director, Safety Scientist responsible for leading safety signal detection, evaluation of safety data, risk assessment, regulatory responses, and periodic reporting for assigned compounds. Provides medical safety assessment and communicates with internal and external stakeholders to ensure compliance with global regulations.

Responsibilities

• Signal and Safety Data Evaluation: identify, analyze, and evaluate safety signals; define data acquisition strategy; perform safety data analysis; lead cross-functional collaboration; present safety data at governance meetings; develop safety communication documents.
• Clinical Trial Support: review safety data; monitor patient safety in trials; author safety sections of protocols, IBs, ICFs, SAPs, TFLs, CSRs, and other documents; respond to ad-hoc safety queries; prepare safety sections of regulatory submissions; create HA briefing materials; train investigators; risk assessment and periodic reporting.
• Author Health Hazard Evaluations: contribute to integrated Benefit/Risk assessments.
• Promote and Advance Pharmacovigilance: engage with internal and external stakeholders; contribute to staff development and Safety Science training; improve organizational effectiveness; ensure compliance with quality systems.
• Supervisory Responsibilities: may have direct reports; provide leadership and safety analysis support within a matrix team.
• Computer Skills: proficiency with safety databases (Argus), MedDRA, signal management, MS Office, Veeva, and data mining tools (Spotfire, PowerBI).
• Other Qualifications: matrix management experience; clinical knowledge; ability to prioritize multiple deliverables; regulatory agency interaction experience; pharmaceutical development experience; global pharmacovigilance knowledge.

Qualifications

• Education Required: PharmD, NP, RN, or PhD in medical field or biological science with 8+ years of Safety (Pharmacovigilance) experience; or MD with relevant clinical training and 6+ years in Safety Science/Clinical Development is preferred.
• Travel: Less than 10%

Skills

• Pharmacovigilance expertise and scientific/clinical judgment
• Strong communication and stakeholder management
• Signal management and safety data analysis
• Regulatory submission and inquiry handling
• Team leadership and collaboration in a matrix environment

Education

• PharmD, NP, RN, or PhD in a medical field or biological science; or MD with relevant clinical experience

Additional Requirements

• Ability to lead complex safety assessments and regulatory interactions
• Experience with regulatory reporting standards and global pharmacovigilance requirements