Director​/Senior Director, Safety-PV Operations Lead

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director/Senior Director, Safety-PV Operations Lead based in United States.

This is a senior pharmacovigilance leadership role responsible for shaping and executing global safety operations across late-stage clinical development and commercialization activities.
You’ll own the operational safety model, ensuring it remains lean, agile, compliant, and capable of supporting complex global programs.
The role combines strategic oversight with hands‑on execution, including vendor management, safety documentation, signal management, and regulatory readiness.
You’ll work closely with medical safety, regulatory, quality, biostatistics, medical writing, and external partners to maintain high standards of patient safety and compliance.
The position offers significant influence over safety processes, governance, systems, and operational strategy within a fast-moving biotechnology environment.
You’ll collaborate across North America, Europe, and Israel, working with distributed teams and external vendors in a highly flexible setting.
This is an opportunity to make a meaningful contribution to global drug development while helping build scalable safety capabilities for future commercialization.

• Provide strategic direction for global safety and pharmacovigilance operations, ensuring an effective, compliant, and cost‑efficient operating model.
• Develop, maintain, and oversee safety operational documents and agreements with external partners, including Joint Operating Guides, Safety Management Plans, and Safety Data Exchange Agreements.
• Coordinate the development of core safety documents, including DSURs, Reference Safety Information within Investigator's Brochures, CCSI, and RMP/REMS materials, in collaboration with Regulatory Affairs.
• Coordinate high‑quality safety outputs with Biostatistics, Quality Assurance, medical writing, and external vendors.
• Support ongoing safety surveillance, including signal management, risk assessment, and periodic safety reporting.
• Serve as the primary point of contact for safety vendors and CROs, managing work orders, budgets, deliverables, administrative requirements, and overall performance.
• Monitor vendor safety KPIs, ensure adherence to Safety Management Plans, and oversee implementation of required risk mitigation measures.
• Establish and maintain safety procedures, governance models, and SOPs appropriate to the stage of product development and future commercialization.
• Partner with Quality Assurance to ensure appropriate safety training is implemented, completed, and documented.
• Work closely with global medical safety leadership and represent safety operations in governance and decision‑making forums.
• Collaborate with Regulatory Affairs, PV Quality Assurance, medical writing, and other internal functions to align safety expectations and maintain regulatory compliance.
• Represent safety operations in interactions with development and commercialization partners.
• Participate in clinical trial teams and expanded‑access or compassionate‑use programs as required.

• Advanced degree such as a PhD, PharmD, MSc, or equivalent in a life‑science or medical discipline.
• At least 5 years of experience in a comparable pharmacovigilance or safety operations leadership role, with experience across both small biotechnology and larger pharmaceutical organizations.
• Demonstrated experience supporting late‑stage clinical development, initial commercialization, and compassionate‑use or expanded‑access programs.
• In‑depth knowledge of global pharmacovigilance and safety requirements, including GVP and 21 CFR Part 11.
• Strong understanding of pre‑ and post‑marketing safety requirements and global regulatory expectations.
• Experience creating and maintaining CCSI and initial RMP/REMS documentation.
• Experience interacting with regulatory authorities such as the FDA, Health Canada, and EMA/PRAC regarding risk management and risk minimization activities.
• Practical experience with safety systems and tools, including Argus, Veeva, and MedDRA.
• Proven ability to manage CROs,…