Medical Safety Officer - Solid Tumors Oncology

Job Overview The Medical Safety Officer (MSO) is a physician who reports to the Global Medical Safety (GMS) organization and manages the medical safety of Innovative Medicine products. The MSO oversees safety assessments of assigned drugs within a Therapeutic Area (TA), collaborates with cross‑functional teams, and leads risk mitigation strategies. Locations Horsham, Pennsylvania; Raritan, New Jersey; Titusville, New Jersey Responsibilities Strategically lead Safety Management Teams (SMT) for assigned products, overseeing safety surveillance, signal detection, risk management plans (RMP), and REMS. 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 patient impact by participating in protocol design. Contribute safety input to key regulatory and clinical documents: risk management plans, safety development plans, clinical trial protocols, informed consent forms, safety sections of Investigator’s Brochures, clinical study reports, and annual safety reports. Prepare Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings. Develop and maintain periodic benefits‑risk evaluation reports (PBRER/PSUR), respond to health‑authority queries, and produce core data sheets. Communicate medical safety findings verbally and in writing to GMS Leadership, CMO, Medical Safety Council, Health Authorities, and external key opinion leaders. Participate in due‑diligence teams evaluating licensing and acquisition opportunities. Oversee contractors and non‑physician staff preparing safety evaluations: define questions, develop strategies, interpret results, review and sign off on reports. Collaborate across GMS TAs to improve common processes, SOPs, work instructions, guidelines, and tools. Lead or participate in department‑wide initiatives and delegate responsibilities for other MSOs and SMT chairs. Perform other duties as assigned. Minimum Qualifications Physician (MD or equivalent) with 2–5 years of pharmacovigilance or related experience (clinical research, medical affairs, or clinical). Board Certified, Board Eligible, or equivalent preferred. Preferred medical specialization. Minimum 1 year of clinical practice experience. Knowledge of drug development principles, pharmacology, clinical trial design, medical monitoring, drug risk assessment, and global safety regulations. Able to influence, negotiate, and communicate with internal and external stakeholders. Experience with Health Authority presentations preferred. Required Technical Knowledge and Skills Leading global cross‑functional teams strategically. Collaborating and building consensus across functions. Strategic thinking with a global mindset and big‑picture orientation. Critically evaluating safety data from diverse sources and presenting findings clearly. Knowledge of Good Clinical Practices and pharmacovigilance regulatory requirements in the US, EU, and globally. Planning work to meet deadlines and managing multiple priorities. Excellent verbal and written communication, including formal presentation skills. Fluency in written and spoken English. Proficiency in Word and PowerPoint preferred. Pay and Benefits Base pay range: $199,000 – $342,700. Annual performance bonus and long‑term incentive program available. Eligible for medical, dental, vision, life insurance, short‑ and long‑term disability, and legal insurance. Retirement: Company 401(k) plan with potential pension. Time off: up to 120 hours of vacation, up to 40 hours of sick time (56 in Washington state), and up to 13 days of holiday pay each calendar year. Equal Opportunity Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by law. We actively seek qualified veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Contact our Employee Health Support Center for accommodation requests. #J-18808-Ljbffr Johnson & Johnson Innovative Medicine