Product Safety Head – Solid Tumors

Johnson & Johnson

. Oversee deliverables and provide strategic direction for 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 compliance with global regulatory requirements and effective communication with stakeholders. Proven ability to lead teams, manage complex safety issues, and develop policies that prioritize patient safety.

Highest-signal resume keywords

Medical Safety StrategyPharmacovigilanceRegulatory ComplianceLeadership SkillsClinical Medicine

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceRisk ManagementClinical Trial MethodologySafety AssessmentDrug DevelopmentOncology KnowledgePost-Marketing Safety AssessmentRegulatory FilingsData EvaluationPolicy Development

Soft Skills

Communication SkillsInfluencing SkillsNegotiation SkillsTeam LeadershipProblem-Solving

Tools & Technologies

Microsoft ExcelMicrosoft Word

Certifications & Qualifications

Physician (MD or Equivalent)

Industry Keywords

Pharmaceutical IndustryGood Clinical PracticesClinical Safety DataHealth AuthoritiesDiversity and InclusionRisk-Benefit AssessmentSafety ProfilesClinical MonitoringRegulatory Inspection ReadinessHealth Hazard Evaluations

About the role

Key responsibilities & impact

Oversee deliverables and provide strategic direction for 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-related processes, systems and practices and implement new approaches
Ensure proactive and timely assessment of safety data and emerging and known product safety profiles
Prepare 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 on product safety concerns
Provide medical expertise and leadership to Product Medical Safety Officers and safety analysis scientists
Provide input into regulatory documents, including Ad hoc reports, Health Hazard Evaluations, Clinical Overviews, PBRERs/PSURs and REMS/RMPs
Serve as designated GMS leader and signatory on program Labeling Committees
Implement and ensure compliance with post-marketing risk management commitments
Ensure consistency of medical safety processes and maximize operational efficiencies
Serve as Safety Representative on the Sponsor Committee for the Independent Data Monitoring Committee
Provide input on pharmaceutical licensing and acquisitions
Support annual budget and resource allocation management
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
Act ethically and responsibly with patient safety as a priority
Lead written and verbal 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
Demonstrated strong CREDO values
Proven leadership skills
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 interactions with domestic and international regulatory departments/agencies
Ability to manage multiple critical issues simultaneously and evaluate data from multiple sources
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 PV 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 Excel and Word
Oncology therapeutic area experience preferred
Experience presenting to technical and lay groups at public meetings desirable
Written skills evidenced by publications and journal articles desirable

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