Director, Pharmacovigilance, Global Programs

Zai Lab (US) LLC•South San Francisco, CA

12h•$221,000 - $310,000•Onsite

About The Position

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.

Requirements

BS in health‑related scientific discipline with 12 years relevant pharmaceutical or biotech industry experience of which 8 years are within pharmacovigilance / drug safety; or equivalent combination of higher education, training and experience.
Demonstrated expertise in signal detection and evaluation, benefit–risk and causality assessment, and authoring global regulatory safety documents.
Strong knowledge of global pharmacovigilance regulations and methodologies (e.g., ICH, GVP, FDA, EMA).
Proven ability to lead and influence within a complex, global matrix organization.
Excellent scientific writing, communication, and presentation skills, including engagement with executive leadership.
Working knowledge of pharmacoepidemiology, statistics, or real‑world evidence.
Demonstrated strategic thinking, sound judgment under pressure, and comfort managing ambiguity.
Resilient and adaptable, with a strong commitment to patient safety, regulatory compliance, and continuous improvement.
Maintains the highest standards of integrity, ethics, and professional conduct.

Nice To Haves

Advanced degree preferred.
Experience in Oncology, Neuroscience and/or Immunology strongly preferred.

Responsibilities

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.
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.
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 and governance committees.
Provide evidence-based information and collaborate with safety physicians to make safety-related decisions, balancing patient safety, regulatory expectations, and program objectives.
Collaborate across several time zones and travel up to 10%.
Represent the organization during regulatory authority interactions, audits, and inspections related to pharmacovigilance activities.
Interact with external expert consultants regarding safety issues and policies.
Maintain awareness of the evolving global pharmacovigilance and regulatory landscape, particularly as it relates to oncology and immunology therapies, and translate changes into actionable safety strategies.