Associate Director, Safety Operations

Role Summary

Associate Director, Safety Operations. Responsible for overseeing daily operations of the Safety team, managing safety reporting compliance, and solving complex project management issues within the safety function. Role may be based in San Francisco, CA or Boston, MA with travel.

Responsibilities

• Ensuring timely and accurate processing of safety reporting to regulatory authorities, investigators, ethics committees, and business partners within timelines and SOPs.
• Managing safety reporting compliance.
• Drafting and reviewing pharmacovigilance documents.
• Preparing metrics related to safety reporting and reporting to upper management as needed.
• Collaborating with Clinical Operations, Data Management and Biostatistics; participating in meetings with cross-functional teams, CROs, and business partners.
• Managing vendors, audit and inspection readiness, 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 including SOPs and guidelines.
• Performing SAE reconciliation.
• Training internal and external groups in Pharmacovigilance principles and best practices.
• Working with safety vendor for daily operations tasks and implementing key action items.

Qualifications

• Required: BA/BS in life sciences, pharmacy, nursing, or related degree; 7‚Äì10 years of pharmaceutical industry experience with at least 5 years in safety; experience with drug safety databases.
• Preferred: Broad clinical/medical knowledge; pharmacovigilance expertise; proficiency with safety systems; strong understanding of global pharmacovigilance regulations, clinical trial methodology, and GCP; experience managing external vendors and audit/inspection readiness; pre-commercial and commercial launch readiness.

Skills

• Excellent presentation, communication, and interpersonal skills; strong written and verbal communication; ability to collaborate cross-functionally.
• Strong organizational, project management, technical, and problem-solving abilities.
• Ability to work independently, take initiative, and adapt to changing priorities.

Education

• BA/BS degree in life sciences, pharmacy, nursing, or related field.

Additional Requirements

• 5% travel required.