Medical Safety Lead

Major Accountabilities

• Monitor clinical safety of projects/products, including literature review, evaluation of individual cases, signal detection, and responses to safety-related questions.
• Perform medical assessments and related activities for single cases, including follow-up information collection, evaluation of product quality defects with adverse events, and preparation of periodic medical assessments for ethics committees.
• Identify safety signals based on the review of solicited or unsolicited single cases. Conduct signal detection, monitoring, and evaluation using proper tools.
• Provide inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues. Prepare safety data for Health Authority review boards and legal queries.
• Support GPSL and Senior Medical Safety Lead in submission activities by providing pharmacovigilance inputs and preparation of safety documents (eg, summary of clinical safety, clinical overview).
• Prepare medical input to aggregate clinical safety regulatory reports.
• Collaborate on the preparation of Safety Profiling Plan (SPP) and Risk Management Plan (RMP) updates. Provide guidance on coding and causality/expectedness assessment of adverse event reports.
• Provide expert evaluation on the clinical context of adverse event reports and their implications on Novartis products.
• Collaborate with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology, and other departments on clinical safety tasks.
• Provide safety inputs for clinical and regulatory deliverables, including clinical study protocols, clinical study reports, and investigator brochures. Support licensing activities, regulatory authority inspections, and project/product recall activities.

Minimum Requirements

• Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD in a relevant field or Medical Degree (MBBS or MD) required. Medical degree with specialization preferred. Medical degree is essential for associates performing medical review of single case reports.
• Relevant experience (eg, clinical, postdoctoral) after graduation.
• At least 4 years in drug development in a major pharmaceutical company, including 2 years in patient safety at an operational or medical position (or equivalent experience).
• Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics, and writing of publications.
• Proven ability to analyze, interpret, discuss, and present safety information both in writing and orally.
• Experience in preparing or contributing to clinical safety assessments and regulatory reports involving safety information.
• Experience with (safety or other) issue management