Senior Medical Director, Immunology, Global Patient Safety

📋 Description

• Analyze and interpret aggregate safety data and communicate these analysis and interpretation to
• Lead and set the strategy for key pharmacovigilance documents, including but not limited to
• Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV
• Understanding of the relevant to the patient safety evaluations pharmacology, and non-clinical
• Effectively write, review and provide input on technical documents independently
• Oversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs

🎯 Requirements

• MD / DO with 2+ years of patient management experience required
• 5+ years of patient safety experience in the pharmaceutical industry, including relevant leadership
• Prior involvement in marketing authorization application submissions or other relevant regulatory
• Prior experience in pharmaceuticals’ clinical development
• Immunology/Internal medicine experience is strongly preferred
• Effectively analyze and guide analysis of clinical data and epidemiological information

🎁 Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick)
• Long-term incentive programs