Medical Review Safety Physician (Director, MRSP) Oncology

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Product Safety

Job Sub Function:

Product Safety Risk Management MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Horsham Pennsylvania United States of America Raritan New Jersey United States of America Titusville New Jersey United States of America

Job Description:

Johnson & Johnson is recruiting for a Director Medical Review Safety Physician (MRSP) - Oncology to be located in Horsham PA Raritan NJ or Titusville NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company.

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at Job Duties and Responsibilities

The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process; this includes single case signal detection activities for selected products and may also include operational aspects of individual case medical review.

The Director Medical Review Safety Physician (MRSP) has primary responsibility for determining the medical and scientific relevance of adverse event reports within the context of the products safety profile as well as other products within the same therapeutic area. These responsibilities include spontaneous reports clinical and non-clinical studies literature reports and other sources of safety data. Additionally MRSPs participate in matrix management activities (e.g. Safety Management Team (SMT)) and provide pharmacovigilance expertise on individual case reports. MRSPs 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.

The Director MRSP has additional responsibility to play a significant role as a senior technical leader of internal and external business initiatives.

Active participation in MRSP activities which may include but are not limited to:

• Analysis and assessment of SUSARs (may perform medical review of Individual Case Safety Reports (ICSRs) from all case types)

• Analysis and assessment of Critical Cases (DME EVOI etc.)

• Detection of single case signals/ through validation and provide recommendations for evaluation

• Member of Safety Management Team

• Active participation in Signal Evaluation

• Ensure Follow-up of all critical case/ Events of Special Interest (RMPs identified risks)

• PBRER/PADER activities

• Investigator Brochure activities

• Watchlist activities

• Targeted Follow-up Questionnaires

• Vendor oversight activities

• Additional ad hoc activities that may require physician input

• Mentor new hires and Fellows as needed.

Identification and analysis of new safety signals and trends by conducting systematic reviews of aggregate data

o Perform signal detection activities for selected products

o Perform validation for signals identified in reviews.

o Prepare summary analysis of safety data for the PSRs/SMTs and provide recommendations for further evaluation.

Participation in pharmacovigilance matrix-teams (i.e. Safety Management Teams) responsible for pharmacovigilance activities focused on products and therapeutic areas as assigned

Support GMS Product Teams and GMSO in general to drive change increase efficiency effectiveness and quality and foster alignment across GMS and with key stakeholders

Lead cross functional projects/teams as assigned (e.g CAPAs Audits/inspections Health Authority impact assessments)

Minimum Qualification

• 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.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

199000 - 343275

Additional Description for Pay Transparency:

The anticipated base pay range for this position is: $199000-$343275 The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Employees are eligible for the following time off benefits: 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 Additional information can be found through the link below. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. 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 federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.