Associate Director, Safety Operations

Role Summary

Associate Director, Safety Operations – reporting to the Director of Safety Operations, responsible for solving complex project management issues, overseeing daily operations of the Safety team, and managing safety reporting compliance.

Responsibilities

• Ensuring timely and accurate processing of safety reporting to regulatory authorities, investigators, ethics committees, and business partners within timelines and in accordance with SOPs
• Managing safety reporting compliance
• Drafting and reviewing pharmacovigilance documents
• Preparing and presenting metrics related to safety reporting to upper management
• Collaborating with cross-functional teams (Clinical Operations, Data Management, Biostatistics) and participating in meetings with cross-functional teams, CROs, and business partners
• Managing vendors, audit and inspection readiness and implementation, pre-launch activities, pre-commercial and commercial launch, and NDA safety operations
• Assisting with study start-up and management of new/future studies
• Spearheading development of departmental systems, SOPs, and guidelines
• Performing SAE Reconciliation
• Training internal and external groups in Pharmacovigilance principles and best practices
• Coordinating with safety vendors for daily operations tasks and implementing key action items

Qualifications

• Required: BA/BS degree in life sciences, pharmacy, nursing, or related field
• Required: 7-10 years of pharmaceutical industry experience, with at least 5 years in safety
• Required: Excellent understanding of pharmacovigilance practices and global pharmacovigilance regulations (EU, US, Canada), clinical trial methodology, and GCP
• Required: Strong presentation, communication, and interpersonal skills
• Required: Experience managing external vendors, audit/inspection readiness, pre-commercial and commercial launch readiness
• Required: Strong organizational, project management, technical, and problem-solving skills
• Preferred: Prior experience with drug safety databases

Skills

• Pharmacovigilance expertise
• Cross-functional collaboration
• Vendor management
• Audit and inspection readiness
• SAE reconciliation

Education

• BA/BS in life sciences, pharmacy, nursing, or related discipline

Additional Requirements

• Role may be based in San Francisco, CA or Boston, MA with up to 5% travel