Director/Senior Director, Safety-PV Operations Lead

Accountabilities:

• • 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.

  Requirements:

  • 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, vendors, and other external partners while maintaining quality, timelines, budgets, and compliance.
  • Strong written and verbal communication skills, with the ability to work effectively across technical, clinical, regulatory, and operational audiences.
  • Hands-on, solution-oriented approach with the willingness to take ownership and drive critical documentation and processes to completion.
  • Ability to work independently while collaborating effectively within a distributed, cross-functional organization.
  • Willingness to travel occasionally for face-to-face meetings and collaborate across North American, European, and Israeli time zones.

  Benefits:

  • Full-time, remote position with a flexible working environment.
  • Opportunity to work across international teams spanning Europe, North America, and Israel.
  • Flexible schedule designed to support collaboration across multiple time zones.
  • Opportunity to contribute to late-stage clinical development and future commercialization programs.
  • Significant ownership and strategic influence over global safety and pharmacovigilance operations.
  • Occasional travel for in-person meetings and team collaboration.
  • Inclusive and collaborative environment focused on meaningful patient impact.
  • Equal opportunity workplace committed to diversity, inclusion, and a welcoming culture.