Product Safety Head – Solid Tumors

Johnson & Johnson

. Oversee deliverables and strategic direction of Medical Safety Officers and Safety Analysis Scientists .

Posted 10/27/2026full-timeUnited StatesSenior💰 $196,000 - $342,700 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in medical safety strategy, risk management, and pharmacovigilance within the pharmaceutical industry, with a strong focus on oncology products and regulatory compliance. Proven ability to lead teams, communicate effectively with stakeholders, and manage complex safety issues throughout the product lifecycle.

Highest-signal resume keywords

Medical Safety StrategyPharmacovigilanceRegulatory ComplianceLeadership in Pharmaceutical IndustryClinical Trial Methodology

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MedicineRisk-Benefit AssessmentSafety AssessmentPost-Marketing Safety AssessmentDrug DevelopmentPharmacologyMedical MonitoringRegulatory FilingsGood Clinical PracticesOncology Products Knowledge

Soft Skills

Leadership SkillsCommunication SkillsNegotiation SkillsInfluencing SkillsTeam Building

Tools & Technologies

Microsoft Office SuiteExcelWord

Certifications & Qualifications

Physician (MD or Equivalent)

Industry Keywords

Pharmaceutical IndustryClinical TrialsPharmacovigilance Regulatory RequirementsSafety Risk MitigationDiversity, Equity, and Inclusion

About the role

Key responsibilities & impact

Oversee deliverables and strategic direction of Medical Safety Officers and Safety Analysis Scientists
Lead end-to-end medical safety strategy and risk management for marketed and developmental pharmaceutical products
Determine the need for safety risk mitigation measures
Align safety activities around common processes, systems, and practices
Ensure proactive and timely assessment of safety data and emerging and known product safety profiles
Oversee preparation of aggregate safety reports and responses to Health Authorities
Communicate potential and known risks to senior management, Health Authorities, prescribers, and patients when appropriate
Partner with senior safety, medical, regulatory, and R&D leaders throughout the product lifecycle
Provide medical expertise and leadership to Product Medical Safety Officers and safety analysis scientists
Provide input into regulatory documents and serve as designated GMS leader and signatory on program Labeling Committees
Implement and comply with post-marketing risk management commitments
Ensure consistency of medical safety processes and implement process improvements
Serve as Safety Representative on the Sponsor Committee for the Independent Data Monitoring Committee
Provide input on licensing and acquisition pharmaceutical candidates
Support annual budget and resource allocation planning
Support regulatory inspection readiness, inspections, and CAPAs
Develop or revise SOPs as Business Process Owner or functional stakeholder
Promote diversity, equity, and inclusion and build a diverse workforce
Lead regulatory authority interactions regarding safety and risk management
Ensure compliance with global legislation and regulatory requirements
Grow, attract, retain, and develop talent and build effective teams

Requirements

What you’ll need

Physician (MD or equivalent)
10 or more years of substantial Pharmaceutical Industry experience
Clinical experience highly preferred
Management experience supervising a group of employees
Proven leadership skills and ability to thrive in a global, matrix environment
Significant skills in clinical medicine and pharmacovigilance, including post-marketing safety assessment experience
Knowledge of oncology products and associated PV guidelines and global regulatory framework
In-depth knowledge of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, risk-benefit assessment, and safety assessment of marketed and developmental compounds
Track record dealing with difficult safety issues, clinical safety data, and domestic and international regulatory departments/agencies
Ability to manage multiple critical issues simultaneously and critically evaluate data from clinical trials, post-marketing environment, and literature
Ability to influence, negotiate, and communicate with internal and external customers
Ability to develop, implement, communicate, and influence policy and strategy
Excellent verbal and written communication skills, including formal presentation skills
Knowledge of Good Clinical Practices and pharmacovigilance regulatory requirements
Knowledge of clinical trial conduct and contributions to regulatory filings, PV documents, and risk management plans
Fluent in written and spoken English
Working knowledge of Microsoft Office Suite, including Excel and Word

Benefits

Comp & perks

Health insurance
Savings plan
Pension plan
Disability plan
Long term incentives
Vacation pay
Sick time
Holiday pay
Work, personal and family time off
Wellness, career and life journey support resources