Medical Review Safety Physician (Director, MRSP) - Oncology

Johnson & Johnson • Titusville, PA

13d • Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com 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 https://www.jnj.com/innovative-medicine Essential 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 product’s 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.

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.

Responsibilities

• 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)

Benefits

• 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 Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree