Senior Director, Patient Safety & Pharmacovigilance

Job Description

Job Description

Location:  San Francisco, Thousand Oaks, or Washington, DC  

Position Summary:

The Senior Director, Patient Safety & Pharmacovigilance reports to the Senior Vice President, Global Regulatory Affairs and provides strategic and operational leadership for patient safety and pharmacovigilance (PV) activities across Latigo's portfolio. This role oversees safety surveillance, signal management, aggregate reporting, PV operations and systems, vendor oversight, compliance, and inspection readiness while partnering cross-functionally to maintain a compliant and scalable pharmacovigilance function.

Key Responsibilities:  

Safety Strategy, Surveillance & Signal Management  

• Lead safety surveillance, signal detection and management, risk management, and benefit-risk assessment across development and post-marketing programs.
• Review and interpret safety data, including case reviews, signal assessments, aggregate analyses, and characterization of product safety profiles.
• Partner cross-functionally to support safety analyses and ensure clear communication of safety findings across clinical, regulatory, and scientific documents.

Safety Documentation & Aggregate Reporting 

• Lead preparation, review, and submission of global aggregate safety reports, including DSURs, PSURs/PBRERs, PADERs, and other required reports.
• Provide safety leadership for key safety documents and global regulatory submissions, including Risk Management Plans, Investigator's Brochures, study reports, and health authority interactions.

Pharmacovigilance Operations  

• Oversee end-to-end PV operations, including case processing, medical review, regulatory reporting, and safety data exchange activities.
• Establish scalable PV processes, metrics, and quality systems while driving continuous improvement in compliance, efficiency, and operational performance.

PV Systems & Technology  

• Provide strategic oversight of PV systems and technologies to support compliant safety surveillance, case management, and regulatory reporting.
• Ensure validated system environments, data integrity, and adoption of technology solutions that improve quality, efficiency, and scalability.

Vendor & Partner Governance 

• Oversee PV vendors, CROs, and service providers, including governance, performance management, and compliance oversight.
• Ensure effective operational partnerships, safety data exchange processes, and inspection readiness.

Safety Governance & Cross-Functional Leadership  

• Lead cross-functional safety governance and serve as the SME for patient safety and PV.
• Build strong partnerships across development functions to support timely, science-based safety decisions.
• Present safety assessments and benefit-risk evaluations to leadership, investigators, DSMBs/DMCs, and regulatory authorities.

Quality, Compliance & Inspection Readiness  

• Maintain PV compliance and inspection readiness across internal and outsourced operations.
• Support audits and inspections, manage CAPAs, and ensure alignment with evolving global PV regulations and best practices.

Organizational Development & Scalability  

• Develop and evolve a scalable PV operating model that supports portfolio growth, geographic expansion, regulatory submissions, and commercialization. 
• Anticipate future resource, infrastructure, technology, and capability needs and contribute to org design, resource planning, and outsourcing strategies.

Qualifications & Experience  

• Bachelor's degree in life sciences, pharmacy, nursing, public health, or a related scientific discipline required; advanced degree (PharmD, PhD, MD, MPH, MS) preferred. 

• 10+ years of experience in patient safety, pharmacovigilance, safety science, or related functions within the pharmaceutical or biotech industry. 

• Significant experience supporting clinical-stage drug development, with strong knowledge of global PV requirements from IND through commercialization. 

• Expertise in safety surveillance, signal detection and management, aggregate safety analysis, benefit-risk assessment, and global ICSR reporting. 

• Experience authoring and reviewing key safety documents, including DSURs, PSURs/PBRERs, IBs, CSRs, and regulatory safety submissions. 

• Experience overseeing outsourced PV operations, including CROs, safety vendors, and related governance activities. 

• Proficiency with PV databases and tools (e.g., Argus), including MedDRA and WHO Drug dictionaries. 

• Strong knowledge of global PV regulations and guidelines, including FDA, EMA GVP, and ICH requirements.
• Experience supporting regulatory inspections, maintaining inspection readiness, and implementing compliant PV processes and systems.
• Strong scientific leadership and analytical skills, with the ability to influence stakeholders, make risk-based decisions, and balance strategy with hands-on execution in a fast-paced biotech.

• Experience supporting NDA and/or MAA submissions and experience in pain therapeutics or neuroscience are preferred.