Associate Principal Scientist, Medical Safety Review Physician

Task:

In-line medical review of individual case safety reports (ICSRs) from clinical trials and other sourcesDetermination or confirmation of need for expedited reporting to regulatory agenciesEnsuring quality, coherence, and accuracy of case narrativesPerforming medical assessment of cases in context of available safety data and known safety profileProviding company statement and causality assessment for Individual Case ReportsGenerating medical queries to improve accuracy and completeness of case reportsEnsuring compliance with global expedited reporting timelinesPerforming Analysis of Similar Events (AOSE) under directionParticipating in quality review of ICSRs from other ICMR Physicians and AssociatesLeading or participating in cross-functional projects as ICMR subject matter expertConsulting with Clinical Director and Clinical Safety and Risk Management Physician for complex casesParticipating in training of the specified ICMR TeamParticipating in process, quality, innovation, technology and other business-related activitiesParticipating on special projects or rotational assignments within or outside of

ICMR Expectation:

M.D. or equivalent Ex US degree in MedicineMinimum of 1 year experience in clinical medicine following trainingMinimum of 3 years relevant work experience including clinical medicine practice post training and pharmaceutical industry experienceStrong understanding of scientific and medical conceptsExcellent writing and communication skills in EnglishEffective presentation skills and experience influencing and negotiatingComputer skills including use of database and basic MS Office suite applicationsProblem-solving skillsConflict resolution skillsCritical thinking skills

Other:

Medical specializationExperience in drug safety, pharmacovigilance and/or risk managementPrior medical review and/or case management experienceRelevant Safety Systems Experience (e.g., Argus, ARIS-G)Drug development experience (early or late phase clinical research, regulatory affairs, and/or safety/PV)Demonstrated leadership skills in managing programs and processes, leading meetings, and influencing peers and direct reportsExperience working and collaborating with global teams What we offer: Regular employee statusHybrid flexible work arrangements Company details: We are one company, but we operate under two different corporate brand names. We are known as Merck & Co., Inc., Rahway, NJ, USA in the United States, Canada & Puerto Rico. We are known as MSD everywhere else.