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
- 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
Experience in clinical safety, post-marketing surveillance, and global safety regulations is highly valued.
Location options
Location options include Horsham, PA, and Raritan/Titusville, NJ, with no specific travel mentioned.
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This position is listed as full time and onsite.