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Manager, Safety Analysis Scientist
Johnson & Johnson. Lead safety evaluations, including strategy discussions, data retrieval, data analysis, report writing, and report revision .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in safety evaluations, medical writing, and pharmacovigilance, with a strong ability to analyze complex medical data and prepare high-quality reports. Proven leadership in cross-functional team environments and effective communication with stakeholders.
Highest-signal resume keywords
Medical WritingPharmacovigilanceSafety Data AnalysisRegulatory Document ReviewCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data AnalysisReport WritingSafety EvaluationsMedical ConceptsBenefit-Risk Analysis
Soft Skills
LeadershipEffective CommunicationNegotiationInfluencingTeam Collaboration
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPoint
Industry Keywords
HealthcareBiomedical ScienceDrug DevelopmentPost-Marketing SafetyGlobal Safety Health Authority Requirements
About the role
Key responsibilities & impact- Lead safety evaluations, including strategy discussions, data retrieval, data analysis, report writing, and report revision
- Collaborate with the Therapeutic Area Safety Head, Medical Safety Officer, and other team members
- Ensure high-quality safety evaluations and reports with minimal-to-moderate comments and revisions
- Support AD Safety Analysis Scientists on novel projects without defined processes
- Provide input and review for key regulatory or clinical documents
- Demonstrate leadership in the Safety Management Team and support the Medical Safety Officer
- Prepare and present data, compile meeting minutes, and update signal-tracking information
- Lead proactive safety data reviews
- Serve as the product point of contact and mentor team members on complex reports
- Build cross-functional alliances to shape safety-related decisions and outcomes
Requirements
What you’ll need- Bachelor’s Degree required in Healthcare-related or Biomedical Science
- 9+ years industry experience or equivalent with a bachelor’s degree
- Advanced degree preferred in Healthcare-related or Biomedical Science
- 6+ years industry experience or equivalent with an advanced degree
- Medical writing or pharmacovigilance (PV) experience required
- Clinical experience preferred
- Working knowledge of medical concepts and safety activities in drug development and post-marketing
- Familiarity with global safety health authority requirements
- Ability to understand and analyze complex medical-scientific data from broad sources
- Ability to interpret and present complex data to determine benefit-risk impact
- Excellent English verbal and written communication skills
- Ability to interact effectively with team members and business partners
- Ability to work in a cross-functional team environment and demonstrate leadership
- Ability to plan work, meet timelines, and balance multiple priorities
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Ability to influence, negotiate, and connect with internal and external customers
Benefits
Comp & perks- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington employees
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time – up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Inclusive interview process and accommodation support