Medical Review Safety Physician (Director, MRSP) - Oncology job at reputed company in Horsham, PA, Raritan, NJ, Titusville, NJ
Title: Medical Review Safety Physician (Director, MRSP) - Oncology Hybrid Work locations Horsham, reputed company, reputed company of America Raritan, New Jersey, reputed company of America Titusville, New Jersey, reputed company of America time type Full time Job reputed company: At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, 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 reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at jnj.com As guided by Our reputed company, reputed company is responsible to our employees who work with us throughout the world. We reputed company an inclusive work environment where reputed company person is considered as an individual. At reputed company, we respect the diversity and dignity of our employees and recognize their reputed company. Job Function: Product Safety Job Sub Function: Product Safety Risk Management MD Job Category: Scientific/Technology reputed company Job Posting Locations: Horsham, reputed company, reputed company of America, Raritan, New Jersey, reputed company of America, Titusville, New Jersey, reputed company of America reputed company, is reputed company for a Director, Medical Review Safety Physician (MRSP) - Oncology to be located in Horsham, PA, Raritan, NJ, or Titusville, NJ. Remote work reputed company may be considered on a case-by-case reputed company and if approved by reputed 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 reputed company. Join us in developing treatments, finding cures, and pioneering the reputed company from lab to life while championing patients every reputed company of the way. Learn more at https://www.jnj.com/innovative-medicine Essential Job Duties and Responsibilities The objective of this position is to reputed company medical expertise in the evaluation of safety data from a reputed company 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 reputed company the context of the product's safety profile as reputed company as other products reputed company the reputed company therapeutic area. These responsibilities include spontaneous reports, clinical and non-clinical studies, literature reports and other sources of safety data. Additionally, MRSPs participate in reputed company management activities (e.g. Safety Management Team (SMT)) and reputed company 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, reputed company regulatory reports, Risk Management Plans, and interpretation of surveillance and product reputed company data. The Director, MRSP has additional responsibility to play a significant role as a senior technical leader of reputed company business initiatives. reputed company participation in MRSP activities which may include, but are not limited to: Analysis and assessment of SUSARs (may reputed company medical review of Individual Case Safety Reports (ICSRs) from reputed company case types) Analysis and assessment of Critical Cases (DME, EVOI, etc.) Detection of single case signals/ through validation and reputed company recommendations for evaluation Member of Safety Management Team reputed company participation in Signal Evaluation Ensure Follow-up of reputed company critical case/ Events of Special Interest (RMPs identified risks) PBRER/PADER activities Investigator Brochure activities Watchlist activities Targeted Follow-up Questionnaires Vendor reputed company activities Additional reputed company 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 reputed company signal detection activities for selected products reputed company validation for signals identified in reviews. Prepare reputed company analysis of safety data for the PSRs/SMTs and reputed company recommendations for reputed company evaluation. Participation in pharmacovigilance reputed company-teams (i.e. Safety Management Teams) responsible for pharmacovigilance activities reputed company on products and therapeutic areas as assigned Support GMS Product Teams and GMSO in general, to drive change, increase efficiency, effectiveness and reputed company, and foster alignment, across GMS and with key stakeholders reputed company cross functional reputed company/teams as assigned (e.g CAPAs, Audits/inspections, Health Authority reputed company assessments) Minimum Qualification A Physician (MD or equivalent) with a minimum of 2 years of clinical medicine preferred. A reputed company 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. reputed company 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 reputed company customers in reputed company-oriented, reputed company environment is required. Fluent in written and spoken English. Working knowledge of the use of reputed company suite of software products, including reputed company and Word. Must be reputed company 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 reputed company of a large product portfolio is required. Required Skills: Preferred Skills: The anticipated reputed company pay reputed company for this position is : 199,000 - 343,275 Additional reputed company for Pay Transparency: The anticipated reputed company pay reputed company for this position is: $199,000-$343,275 reputed company maintains highly competitive, performance-based compensation programs. Under reputed company 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 reputed company an incentive to reputed company annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at reputed company's discretion on an individual reputed company. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, reputed company, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in reputed company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in reputed company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year reputed company time - up to 40 hours per calendar year; for employees who reputed company in the reputed company - 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 reputed company through the reputed company below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates reputed company in the reputed company. Candidates reputed company reputed company the reputed company will be eligible for compensation and benefits in accordance with their local market. reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We reputed company reputed company reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation reputed company. reputed company 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 reputed company or contact AskGS to be directed to your accommodation resource. Apply tot his job Apply To this Job