Senior Scientist, Risk Management & Safety Surveillance
Core
Leading pharmacovigilance activities to assess medicine safety and benefit-risk profiles, including aggregate safety reports, signal evaluation, and regulatory responses.
Role type
Senior Scientist, Pharmacovigilance & Safety Surveillance
Builds
Aggregate safety reports, risk management plans, regulatory submissions, and safety strategies for marketed and investigational products.
Domain
Life Sciences / Pharmacovigilance / Drug Safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance, aggregate safety analysis, signal evaluation, medical writing, regulatory compliance, project coordination, data interpretation, risk management planning, stakeholder collaboration, scientific judgment
Preferred skills
Clinical medicine experience, therapeutic area expertise, vendor management, health authority query response, label updates, DSUR/PSUR strategy
Technologies
Safety databases, regulatory reporting systems, medical writing tools
Responsibilities
Own and coordinate scheduled and ad hoc aggregate safety reports; Lead signal validation and evaluation activities; Author and review core safety deliverables and strategic documents; Support responses to health authority queries; Provide guidance on Risk Management Plans; Collaborate with therapeutic area leaders and external vendors; Participate in label working groups and safety strategy updates.
Seniority
Senior, hands-on IC
