We are looking for Senior Manager Drug Safety Content Analysis to join our Pharmacovigilance (PV) team (offices working in Hybrid model). This is an amazing opportunity to support the team to perform literature monitoring and assessing for adverse events reporting, indexing, and abstracting by using broad knowledge of scientific terms and medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations.The Senior Manager Drug Safety Content Analysis will manage and supervise project’s AMs/ Managers and project’s PV Operations staff on a day-to-day basis, guiding performance of PV Operations staff in ongoing projects in terms of quality of deliverables, compliance with the timelines and relevant trainings. He/she will also provide process-related expertise for the various project specific activities ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs) and communicate with client for queries/feedback.About You – experience, education, skills, and accomplishmentsMaster’s Degree in life Sciences, Health or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.).A degree in Dentistry/physiotherapy/Nursing, which involves patient exposure in hospital-based environment, would be an advantageAround 10+ years of experience in Pharmacovigilance and atleast 6+ years of team management/project management experienceExcellent leadership and line management skillsExcellent knowledge of drug safety and the drug development processExcellent knowledge and ability to interpret and apply global safety regulations, expert in data analysis and evaluation of safety dataClient focused approach to workAbility to manage multiple and varied tasks and prioritize workload with attention to detailAbility to train and mentor peopleExcellent verbal / written communication skillsExcellent time management skillsIt would be great if you also had the following:Certification from a professional medical writer’s associationExperience with commercial and client-specific biomedical literature databasesScientific/medical writing backgroundWhat will you be doing in this role?Providing functional expertise/oversight of process and handling queries of the PV Operations staffPrepare for and respond to internal/external audits/inspectionsTaking suitable action as per client feedback for any performance or process related concernsProviding project updates to the Senior Management on periodic basisEnsuring to meet the requirements as in-Service Level Agreements and achieving all defined and agreed Key Performance Indicators in terms of quality, compliance and trainingsMaintaining awareness of any performance issues within the team and taking steps for resolutionEnsuring communication of important decisions/policies discussed with senior management or the client to the teamAbout the TeamThe PV Literature team supports multiple customers covering all therapeutic areas. It is a supportive working environment with personalized training, and opportunities to engage in different aspects of pharmacovigilance and participate in customer upgrade planning if desired.Hours of WorkThis is a full-time permanent position working weekdays (Monday to Friday)At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.
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