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About the Role

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 portfolios across the full product lifecycle. 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.

Responsibilities

Provide scientific and strategic leadership for safety evaluation and risk management.
Contribute to and execute global safety strategies.
Ensure regulatory compliance.
Drive scientifically sound benefit–risk decision‑making.
Perform core pharmacovigilance activities including signal detection and evaluation.
Author key regulatory safety documents.
Ensure inspection readiness.
Manage regulatory requests.
Serve as a key safety leader and influencer.
Partner with cross-functional stakeholders.
Represent Safety in governance forums and senior leadership discussions.
Lead the global safety evaluation and risk management strategy for assigned Oncology and NSI products.
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.
Escalate safety issues appropriately to senior management and safety governance bodies.
Perform signal detection and evaluation activities, including review of aggregated safety data, literature surveillance, and real-world evidence.
Lead the planning, coordination, and preparation of key regulatory safety documents (DSURs, PBRERs/PSURs, RMPs, REMS, etc.).
Ensure all safety documentation is scientifically sound, inspection-ready, and compliant with global regulatory requirements.
Oversee pharmacovigilance vendor activities and deliverables.
Manage safety governance committee operations.
Represent safety on cross-functional governance bodies, Safety Review Teams, and Product or Development Teams.
Support pharmacovigilance training and education.
Present safety data, emerging risks, and strategic recommendations to senior leadership.
Provide evidence-based information and collaborate to make safety-related decisions.
Collaborate across several time zones.
Represent the organization during regulatory authority interactions, audits, and inspections.
Interact with external expert consultants regarding safety issues and policies.
Maintain awareness of the evolving global pharmacovigilance and regulatory landscape and translate changes into actionable safety strategies.

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.

Skills

Pharmacovigilance
Drug safety
Signal detection
Benefit-risk assessment
Causality assessment
Risk management
Regulatory compliance
Scientific writing
Communication
Presentation
Leadership
Influence
Strategic thinking
Pharmacoepidemiology
Statistics
Real-world evidence

Location

South San Francisco, CA

Work Type

Full-time
Onsite

Experience Level

Director
12 years relevant pharmaceutical or biotech industry experience
8 years within pharmacovigilance / drug safety

Education Level

BS in health‑related scientific discipline
Advanced degree preferred

Salary/Compensations

$221K - $310K/year

Benefits

Sign-on bonus
Restricted stock units
Discretionary awards
Full range of medical benefits
Financial benefits
401(k) eligibility
Various paid time off benefits (vacation, sick time, parental leave)

About the Company

Zai Lab Limited is an innovative, research-based, commercial-stage biopharmaceutical company focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world.
The company leverages its competencies and resources to positively impact human health worldwide.
Founded in 2014, Zai Lab has secured partnerships with leading global biopharmaceutical companies, generating a broad and late-stage pipeline of innovative drug candidates.
Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to access the Chinese market and find a long-term strategic partner for global clinical development.
The company's unique business model builds on in-licensed assets and innovative partnerships to expand internal discovery and development capabilities.
Zai Lab 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 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.
Zai Lab is proud of the gender diversity of its company and its promotion of women in biotech.
The company has achieved gender base pay equity at all levels.
58% of its employees are women and 54% of its management positions are held by women.
Zai Lab is committed to the health of patients and our planet.
The company's environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life” is integrated within its business.

Equal Opportunity

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.