Director, Pharmacovigilance, Global Programs

Company Description

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world. Our goal is to leverage our competencies and resources to positively impact human health worldwide.

Founded in 2014, our experienced team has secured partnerships with leading global biopharmaceutical  companies, generating a broad and late-stage pipeline of innovative drug candidates. Based on our proven  track record of  success, Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to not only access the Chinese market but also find a long-term strategic partner for global clinical development.  Our unique business model builds on our in-licensed assets and innovative partnerships to expand our internal discovery and development capabilities and has created a portfolio of potential best-in-class and/or first-in-class therapies. Zai currently has four products on the market in China

Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed secondary listing on Hong Kong Stock Exchange in September 2020. In 2022, Zai Lab became dual-primary listed on both the Nasdaq and the Hong Kong Stock Exchanges. Since its inception, Zai Lab has expanded significantly with several offices across China. In 2021, Zai Lab established its U.S. Headquarters in Cambridge, Massachusetts.  As of January 2022, the Company has a global team of approximately 2000 employees.

Job Description

Primary Function:

The Director, Pharmacovigilance Global Programs provides scientific and strategic leadership for the safety evaluation and risk management of products within the Oncology and Neuroscience & Immunology（NSI) portfolios across the full product lifecycle, including clinical development and post‑marketing.

This role is accountable for contributing to and executing global safety strategies, ensuring regulatory compliance, and driving scientifically sound benefit–risk decision‑making to protect patients. The Director works hands‑on in core pharmacovigilance activities, including signal detection and evaluation, authoring key regulatory safety documents, inspection readiness, and managing regulatory requests, while also serving as a key safety leader and influencer. The role partners closely with cross‑functional stakeholders and represents Safety in governance forums and senior leadership discussions.

This position is based in our South San Francisco, CA office.

Major Responsibilities and Duties:

Safety Strategy & Scientific Leadership

• Collaborate with safety physicians to lead the global safety evaluation and risk management strategy for assigned Oncology and NSI products across development and post marketing stages.
• Provide expert scientific judgment in benefit–risk assessment, causality assessment, signal detection and evaluation, and risk minimization.
• Anticipate, identify, and proactively manage complex and emerging safety issues.
• Collaborate with safety physicians to escalate safety issues appropriately to senior management and safety governance bodies, with clear, evidence based scientific recommendations.

Pharmacovigilance Operations & Oversight

• Collaborate with safety physicians in performing signal detection and evaluation activities, including review of aggregated safety data, literature surveillance, real-world evidence, and maintenance of signal tracking documentation.
  • Lead the planning, coordination, and preparation of key regulatory safety documents, including Development Safety Update Reports（DSURs）, Periodic Benefit-Risk Evaluation Reports （PBRERs/PSURs）, EU Risk Management Plans （RMPs）, US Risk Evaluation and Mitigation Strategies （REMS） documents or relevant components, health authority responses, and ad hoc safety assessments.
• Ensure all safety documentation is scientifically sound, inspection-ready, and compliant with global regulatory requirements (e.g., ICH, GVP, FDA, EMA).
• Oversee pharmacovigilance vendor activities and deliverables, ensuring compliant, high‑quality execution of outsourced safety operations.

Governance, Communication & Influence

• Manage safety governance committee operations.
• Collaborate with safety physicians to represent safety on cross-functional governance bodies, Safety Review Teams, and Product or Development Teams.
• Support pharmacovigilance training and education for internal and external stakeholders.
• Present safety data, emerging risks, and strategic recommendations to senior leadership