Medical Safety Officer - PALM

Overview

Johnson & Johnson is seeking a Medical Safety Officer (MSO) - Post Approval Lifecycle Management (PALM) to assess the medical safety of Innovative Medicine products and lead cross-functional teams responsible for product safety and benefit-risk oversight. The MSO reports to the Portfolio Safety Head and collaborates with Global Medical Safety (GMS) to ensure proactive safety assessments across assigned therapeutic areas (TAs) and product life cycles.

Responsibilities

• Strategically lead the Safety Management Teams (SMT) for assigned products, including safety surveillance, signal detection, and risk management activities (RMP/REMS) and other safety-related processes.
• Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams.
• Anticipate safety concerns and influence Clinical teams to minimize/mitigate patient impact by contributing to clinical protocol design.
• Contribute to regulatory and clinical documents with safety input, including risk management plans, clinical trial protocols, informed consent forms, safety sections of Investigator's Brochure, CSR/ASR/ISS/SCS for NDA/BLA/MAA filings, PBRER/PSUR, and related safety documentation.
• Communicate important safety results to the GMS Leadership Team, CMO, and the Medical Safety Council; engage in meetings with Health Authorities and external key opinion leaders.
• Provide medical safety leadership on due diligence teams for Licensing & Acquisition opportunities.
• Oversee contractors and non-physician staff responsible for preparing written safety evaluations, including defining safety questions, developing safety review strategies, interpreting results, and approving medical assessment reports.
• Collaborate across GMS therapeutic areas to harmonize safety data collection, assessment, and risk-management processes; participate in the creation, review, and implementation of SOPs, work instructions, guidelines, and tools related to safety assessment and risk management.
• Lead or actively participate in department-wide initiatives and manage delegated responsibilities for other MSOs and SMT Chairs.

Minimum Qualifications

• Physician (MD or equivalent) with 2-5 years of pharmacovigilance (PV) experience or other relevant experience (e.g., Clinical research, Medical Affairs).
• Board Certified/Board Eligible/equivalent preferred; medical specialization preferred.
• Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience.
• Knowledge of drug development principles, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks/benefits, safety assessment of drugs, and global safety regulations (highly preferred).
• Ability to influence, negotiate, and communicate with internal and external stakeholders; experience with Health Authority presentations is preferred.

Required Technical Knowledge and Skills

• Ability to lead global cross-functional teams effectively and strategically; connect, collaborate, and build consensus across relevant functions.
• Strategic thinking with a global mindset and ability to understand implications for the business.
• Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature) and present findings clearly in written and oral formats.
• Knowledge of Good Clinical Practices and pharmacovigilance regulatory requirements (US, EU, and global); experience with regulatory filings and risk management plans.
• Strong planning skills to meet deadlines and manage multiple priorities; excellent verbal and written communication skills, including formal presentations; publication experience is desirable.
• Fluency in written and spoken English; proficiency in Word and PowerPoint is desired.