SR DRUG SAFETY CASE MANAGER
Company: J&J Family of Companies
Location: Cherry Hill
Posted on: February 1, 2019
Janssen Research & Development, LLC, a member of the J&JFamily of Companies, is recruiting for an SeniorManager, Case Processing to be located preferably in Cherry Hill, NJ or in SouthSan Francisco, CA. Janssen Research & Development, L.L.C. developstreatments that improve the health and lifestyles of people worldwide. Researchand development areas encompass novel targets in neurologic disorders,gastroenterology, oncology, infectious disease, diabetes, hematology, metabolicdisorders, immunologic disorders, and reproductive medicine. The Senior Drug Safety Case Manageris considered to have extensive experience to help the department to improveefficiency and productivity. In addition to their case processingresponsibilities, the job incumbent is prompt to provide new ideas, challengethe status quo, and support Drug Safety management to ensure the effectiveimplementation and coordination of Drug Safety activities from the initial caseassessment to archive for all AE reports received by the US Drug SafetyDepartment in compliance with applicable FDA and global regulations, ActelionStandard Operating Procedures (SOPs) and guidelines. Additionally, the jobincumbent supports process harmonization/ consistency across all data entrysites. The Senior Drug Safety Cases Managerwill: + Takes a proactive role identifying and communicatingopportunities for improvement, identify issues, conducting root cause analysisand proposing solutions. Provides input and strategic direction tomanagement on any related case processing activities associated withher/his assigned role + Plays the role of mentor to others, lead processimprovements. Takes responsibility overseen one or more specific caseprocessing activities. This person supports people's development andtechnical skills + Performs complex medical assessments of adverse eventinformation according to SOP and working instructions + Capable of performing active follow-up via telephonecontact, is able to discuss cases with HCPs, identify and ask for criticaland relevant information + Supports improvements on the quality of all adverseevent information with emphasis on serious and events of interest reportsthat require expedited reporting to authorities. + Assists managers on monitoring case priorities andtimely reportability of adverse event cases to health authorities andcorporate partners + Serves as a PV expert providing safety expertise toother functions such as Medical affairs, clinical teams. Supports clinicaltrial safety activities related to study initiation, reconciliation, andmay assist Drug Safety Physician in preparing Safety Data Managementreports + Contributes to inspection readiness planning. Mayparticipate as a matter expert during regulatory audit interviews + Support GDSS initiatives including the identificationof new applications, user requirement and enhancements, validation testing + Collaborates with the compliance group in SafetyOperations training processes Qualifications Qualifications: + Bachelor's degree (or comparable non-US Degree) inPharmacy, Nursing or related health field + Minimum of 4 years'experience in Drug Safety datamanagement, proficient in case processing and review of safety data required + Three or more years of post-graduate clinicalexperience in hospital or clinical practice settings is an advantage + General knowledge of medical terminology, MedDRA codingand drug dictionaries required + Excellent knowledge of FDA and international adverseevent reporting regulations per International Conference of Harmonization(ICH) Guidelines and the ability to interpret and apply applicableregulation to resolve issues required + Experience using a drug safety database (e.g. ARIS G orArgus) required + Computer proficiency and computer data entry experience(Word, Excel, and Power point) + Critical and strategic thinking + Excellent organizational skills and the ability to workunder pressure and meet tight timelines + Effective verbal and written communication + Strong interpersonal skills. Able to effectivelyinteract with other people both individually and in groups + Working with others to identify, define and solveproblems. Explore options to make good decisions + Good management skills are a plus Johnson & Johnson is an Affirmative Action and Equal OpportunityEmployer. All qualified applicants will receive consideration for employmentwithout regard to race, color, religion, sex, sexual orientation, genderidentity, age, national origin, or protected veteran status and will not bediscriminated against on the basis of disability. Primary Location United States-New Jersey-Cherry Hill- Other Locations North America-United States-California-South San Francisco Organization Janssen Research & Development, LLC. (6084) Job Function Drug & Product Safety Operations Requisition ID 4509190117
Keywords: J&J Family of Companies, Cherry Hill , SR DRUG SAFETY CASE MANAGER, Executive , Cherry Hill, New Jersey
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