VP of Global Drug Safety

Kaye/Bassman International is a leading Pharmaceutical and Biotechnology search firm, filling critical roles in eleven different verticals. Our Drug Safety & Pharmacovigilance practice is led by industry expert Eduardo Marinero: https://www.linkedin.com/in/eduardo-marinero-68336280/We are retained by a commercial-stage company focused on ADCs for cancer treatment that is seeking a dynamic VP of Global Drug Safety reporting directly into the Chief Medical Officer.Key ResponsibilitiesProvide strategic leadership and oversight for global pharmacovigilance operations, including adverse event case processing, medical review, reporting, and regulatory compliance.Lead signal detection, evaluation, and aggregate safety surveillance activities to ensure proactive assessment of benefit-risk profiles across clinical and post-marketing programs.Serve as the senior safety representative on cross-functional product and development teams, advising on safety strategy, risk management, and regulatory decision-making.Ensure the effectiveness and compliance of the pharmacovigilance quality system, including oversight of SOPs, vendor performance, safety databases, and global regulatory requirements.Direct the ongoing evaluation and communication of product safety profiles, including labeling updates, regulatory submissions, investigator brochures, and other key safety documents.Lead a high-performing Drug Safety organization through talent development, resource planning, operational excellence, and strong cross-functional collaboration, including support for business development and partnership activities.RequirementsMD required with significant biopharmaceutical industry experience, including deep expertise in clinical development and pharmacovigilance leadership.Proven track record in global drug safety operations, including periodic safety reporting, benefit-risk assessment, and regulatory support for products in development and post-approval settings.Experience overseeing safety systems, vendors, and pharmacovigilance infrastructure, including safety databases, MedDRA, and WHO Drug coding standards.Demonstrated clinical and analytical expertise within ADCs and/or Oncology, with the ability to operate strategically in a fast-paced development environment.Strong knowledge of global pharmacovigilance regulations and guidelines, including FDA, ICH, GVP, and GCP requirements.Hybrid role based in New Jersey with approximately 10% domestic travel.If you fit the description, please apply. Also, feel free to reach out directly to Eduardo Marinero to begin a confidential discussion.