Medical Review Safety Physician – Oncology
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Horsham • New Jersey • Pennsylvania • United States
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Salary
💰 $199,000 - $343,275 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilanceclinical medicineaggregate safety reportsGood Clinical Practicessafety data evaluationrisk management planscase report evaluationsafety issue evaluationsurveillance data interpretationmatrix management
Soft Skills
communication skillsmentoringteam-orientedindependent workjudgmentleadershiporganizational skillsproblem-solvingcollaborationtime management
Certifications
MDBoard certification