Director/Senior Director, Safety-PV Operations Lead

Job description

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. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 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 Portugal. 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.