Manager, Safety Analysis Scientist

Role: Manager, Safety Analysis Scientist responsible for scientific safety assessments of pharmaceutical products within Johnson & Johnson's Innovative Medicine division. Objectives: provide expert safety evaluations, support regulatory compliance, and contribute to benefit-risk analyses for marketed and developmental drugs. Responsibilities: lead safety data reviews, develop and revise safety reports, collaborate with Medical Safety Officers and cross-functional teams, support regulatory documentation, and mentor team members on complex safety reports. Qualifications: Bachelor's in Healthcare or Biomedical Science with 9+ years industry experience; advanced degrees preferred with 6+ years; background in pharmacovigilance, medical writing, or clinical safety required; knowledge of drug development safety activities and global regulatory standards essential. Skills: strong medical data interpretation, scientific communication, cross-functional collaboration, project planning, and proficiency in Microsoft Office. Experience in clinical safety, post-marketing surveillance, and global safety regulations is highly valued. The position requires independent operation within a team environment, with a focus on high-quality safety evaluations supporting marketed and in-development products. Location options include Horsham, PA, and Raritan/Titusville, NJ, with no specific travel mentioned. The role emphasizes leadership, scientific expertise, and regulatory acumen relevant to biopharma safety and pharmacovigilance in a dynamic, cross-functional setting.