Senior Manager, Safety Data Science (FTC Maternity Cover)
Core
Leads global safety data science activities including signal detection, evaluation, and risk-benefit assessment for pharmaceutical products throughout their lifecycle.
Role type
Senior Manager, Safety Data Science
Builds
Global aggregate safety reports, Clinical Study Reports, Risk Management Plans, and regulatory submissions.
Domain
Pharmaceutical industry, Pharmacovigilance, Drug Safety
Deliverable
client delivery
Required skills
Pharmacovigilance regulations, Signal detection, Signal evaluation, Clinical trial data analysis, Regulatory requirements, Therapeutic area knowledge, Risk minimization strategies, Label change management, Safety database review, Literature review, Medical judgment, Project management, Microsoft Word/Excel
Preferred skills
Drug development process knowledge, Scientific strategy, Operations management, Cross-functional collaboration, Mentoring
Technologies
Safety databases, Clinical trial data systems
Responsibilities
Partner with cross-functional stakeholders to support product safety profiles and benefit-risk; Review safety data from clinical trials, databases, and literature; Analyze data for signal assessments and regulatory requests; Prepare written and verbal summaries of signal management activities for senior management and regulatory authorities; Collaborate on strategies for signal assessments; Mentor and train new safety scientists.
Seniority
Senior, hands-on IC with management responsibilities