(Senior) Patient Safety Physician CRM
Core
Lead or contribute to integrated Patient Safety and Pharmacovigilance (PSPV) activities for compounds in clinical development or post-marketing, focusing on cardiovascular, renal, hepatic, and metabolic diseases.
Role type
Senior Associate Director / Senior Patient Safety Physician (Cardio-Renal-Metabolism)
Builds
Proactive, patient-centric risk minimization strategies and safety evidence for assigned pharmaceutical compounds
Domain
Pharmaceutical industry, pharmacovigilance, clinical development, and post-marketing drug safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical Doctor qualification, clinical and/or clinical research experience, PV experience, understanding of PV regulations in major markets, project management, leadership competencies
Preferred skills
Experience in clinical development and submissions for marketing authorization, clinical or research experience in cardio-renal-metabolism areas
Technologies
Clinical trial and safety databases, regulatory documents (IBs, PSURs, DSURs, RMPs, Clinical Overview Statements)
Responsibilities
Designing and implementing strategies to generate appropriate safety evidence, developing risk minimization strategies, planning and monitoring PV activities, setting up safety analyses, managing safety signals, interpreting clinical trial safety data, reviewing and providing input to regulatory documents, updating senior management on safety profiles, chairing internal Asset Benefit Risk Teams
Seniority
Senior, hands-on IC with leadership and strategic oversight
