Pharmacovigilance Scientist Jobs

About The Position

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.

Nice To Haves

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

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 collaboration with safety physicians 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.

Benefits

• sign-on bonus
• restricted stock units
• discretionary awards
• 401(k) eligibility
• vacation
• sick time
• parental leave