Director, PharmacovigilanceSafety Scientist

Primary Function:

The Director Pharmacovigilance/Safety Scientist provides scientific and operational expertise 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 postmarketing.

This role partners closely with Safety Physicians and cross-functional stakeholders to execute global safety strategies support regulatory compliance and contribute to scientifically sound benefitrisk decisionmaking to protect patients. The Director works handson in core pharmacovigilance activities including signal detection and evaluation authoring key regulatory safety documents inspection readiness and managing regulatory requests in close collaboration with Safety Physicians on matters requiring clinical and medical judgment. The role represents Pharmacovigilance 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 collaboration with safety physicians in benefitrisk 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 ReportsDSURs 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 highquality 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 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%.

External Representation & Inspection Readiness

• 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.

Qualifications :

REQUIRED:

• BS in healthrelated 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.

PREFERRED:

• Advanced degree preferred.
• Experience in Oncology Neuroscience and/or Immunology strongly preferred.
• Demonstrated expertise in signal detection and evaluation benefitrisk 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 realworld 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.

Additional Information :

The pay range for this position at commencement of employment is expected to be between $221K and $310K/year; however base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and experience. The total compensation package for this position may also include other elements including a sign-on bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

At Zai we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels 58% of our employees are women and 54% of our management positions are held by women. We are committed to the health of patients and our planet. Thats why our environmental protection social responsibility and corporate governance strategy called Trust for Life is integrated within our business.

Disclaimer: This description is not intended to be construed as an exhaustive list of duties responsibilities or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time as needed.

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.

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Remote Work :

No

Employment Type :

Full-time