Senior Manager Pharmacovigilance

Job Summary

Leading pharmacovigilance activities for investigational and marketed products, the full-time Senior Manager Pharmacovigilance will provide scientific and strategic leadership, manage complex safety analyses, and engage with regulatory authorities, working in a hybrid remote environment.

Key Responsibilities

• Serve as lead author for complex aggregate safety reports and high-impact safety documents for regulatory submissions
• Lead safety reviews and signal management activities, including the evaluation of individual and aggregate safety data
• Prepare responses to safety-related requests from global health authorities and support product labeling development

Required Qualifications

• MD with 0+ years, Doctorate with 2+ years, Master's degree with 6+ years, or Bachelor's degree with 8+ years of relevant experience
• 5+ years of direct pharmacovigilance experience with aggregate reporting and regulatory support
• Strong knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines
• Experience with safety databases and tools such as Argus, Rave, MedDRA, and WHO Drug
• Demonstrated ability to independently lead complex safety deliverables and make sound scientific judgments