Hybrid Medical Review Safety Physician – Oncology

at Johnson & Johnson

• Job title: Medical Review Safety Physician – Oncology
• Job type: Full Time
• Experience level: Lead
• Salary: $199,000 - $343,275 per year
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Horsham, United States

About the role

• Director of Medical Review Safety Physician focusing on oncology for Johnson & Johnson. Evaluating safety data and mentoring teams while leading pharmacovigilance initiatives.

Responsibilities

• Provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process;
• Participate in matrix management activities (e.g. Safety Management Team (SMT)) and provide pharmacovigilance expertise on individual case reports.
• Support activities such as evaluating safety issues from various sources including Designated Medical Events (DME) and Events of Interest (EVOI).
• Preparation of aggregate safety reports such as PBRERs, ad-hoc regulatory reports, Risk Management Plans, and interpretation of surveillance and product quality data.
• Mentor new hires and Fellows as needed.
• Ensure Follow-up of all critical case/ Events of Special Interest (RMPs identified risks) PBRER/PADER activities.
• Lead cross functional projects/teams as assigned (e.g CAPAs, Audits/inspections, Health Authority impact assessments).

Requirements

• A Physician (MD or equivalent) with a minimum of 2 years of clinical medicine preferred.
• A Board certification (if US) is preferred.
• Medical specialization is preferred.
• A minimum of 4 years of experience in industry, academia or patient care settings is required.
• Direct experience in pharmacovigilance is strongly preferred.
• Experience and knowledge of Good Clinical Practices is required.
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers in a team-oriented, matrix environment is required.
• Fluent in written and spoken English.
• Working knowledge of the use of Microsoft suite of software products, including Excel and Word.
• Must be able to work independently with minimum supervision to meet tight deadlines.
• Significant experience and judgment required to identify and evaluate issues likely to be relevant in understanding safety profiles of a large product portfolio is required.

Benefits

• medical, dental, vision, life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• long-term incentive program
• vacation – up to 120 hours per calendar year
• sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year