Associate Director Senior Patient Safety Scientist
Core
Strategic safety science leadership for oncology drug development, managing safety programs from early to post-marketing phases to protect patients and support regulatory decisions.
Role type
Associate Director, Senior Patient Safety Scientist (Oncology)
Builds
Oncology drug development programs and safety documentation for regulatory submissions
Domain
Pharma / Oncology / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance strategy, signal detection & evaluation, regulatory report authoring, risk management planning, governance board communication, multi-project prioritization, matrix organization navigation, PV regulations knowledge
Preferred skills
Hematology knowledge, epidemiology understanding
Technologies
None stated
Responsibilities
Develop program-level safety strategies including proactive risk identification and mitigation planning; prepare and author safety aspects of Common Technical Documents and marketing authorization applications; deliver strategy and author periodic safety reports and risk management plans; interact with governance boards and cross-functional teams; aggregate, review, analyze, and interpret safety data to support decision-making
Seniority
Associate Director, strategic program leadership
