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Medical Safety Officer – Immunology
Johnson & JohnsonMedical Safety Officer overseeing product safety assessments in Innovative Medicine. Leading cross-functional teams and managing benefit risk oversight for drugs in development and on the market.
About the role
Key responsibilities & impact- Assess medical safety of Innovative Medicine products
- Lead cross-functional matrix teams for product safety and benefit risk oversight
- Proactively assess safety data to characterize safety profiles
- Communicate potential and known risks to relevant stakeholders
- Lead design and implementation of risk mitigation strategies
- Provide medical expertise on development teams
- Collaborate with Clinical teams to minimize patient impact
- Contribute to key regulatory and clinical documents
- Actively participate in meetings with Health Authorities and external leaders
- Provide medical oversight on due diligence teams for Licensing & Acquisition
- Align and improve common processes across teams
- Create, review and implement safety assessment SOPs and tools
- Lead or participate in department-wide initiatives
Requirements
What you’ll need- Physician (MD or equivalent) with 2-5 years of pharmacovigilance (PV) experience or other relevant experience (e.g., Clinical research, Medical Affairs, clinical) required.
- Board Certified/Board Eligible/equivalent preferred.
- Medical specialization preferred.
- Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience.
- Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred.
- Ability to influence, negotiate and communicate with both internal and external stakeholders.
- Experience with Health Authority presentations is preferred.
Benefits
Comp & perks- an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
- vacation days
- parental leave for a minimum of 12 weeks
- bereavement leave
- caregiver leave
- volunteer leave
- well-being reimbursement
- programs for financial, physical and mental health.
- service anniversary and recognition awards
- employees - and in some location’s eligible dependents - can participate in several insurance plans.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Medical Safety AssessmentDrug Development PrinciplesClinical Practice ExperienceSafety Assessment SOPsBenefit Risk Oversight
Soft Skills
Influencing StakeholdersNegotiation SkillsEffective Communication
Certifications
Physician (MD or Equivalent)Board Certified/Board Eligible