Backed by 5AM Ventures.
About the role
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.
What they're looking for
- 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
- 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
- Oversee end-to-end PV operations, including case processing, medical review, regulatory reporting, and safety data exchange activities
More about this role
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.
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...
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