Job Description

General Product Support Supports Medical Safety Assessment Physician (MSAP) leading signal detection activities for a products emerging safety profile. Prepare/write PV sections of aggregate safety documents (eg, DSUR, PBRER, RMP). Write and analyze data for ad hoc responses to health authorities, with oversight. Review and contribute to Clinical Study Reports and Investigator Brochures, depending on phase of development. Execute strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document signal in a Signal Report. Analyze data and prepare documentation to support label updates for assigned products, with oversight. Support Safety input for regulatory product labeling. Support the EU QPPV or other regional or local Qualified Person for safety issues relating to assigned products. Working knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Share with individuals and teams on these applied learnings. Post Marketing Product Support Perform core surveillance activities, signal assessment according to the product stage of development for a multiple coumponds, with oversight, as needed. Lead Safety Data Review Meetings (SDRM) in the review and evaluation of safety data to support signal detection. Appropriately elevate issues impacting key SMT activities, milestones, and documents to the SMT Chair with oversight, as needed. Contributes to specified PV sections of the DSURs, PBRERs and safety data query responses to HAs including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries, with oversight, as needed. Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data. Executes the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Partner with SMT Chair on the evaluation management of signals emerging from any data source. Authors the Signal Report and tracks signals for other means of communication, with oversight, as needed. Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing safety profile, with oversight as needed. Department Activities Support preparation for regulatory inspections and audits with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates. Support hiring orientation in HYD. Cross Functional Activities Support process improvement and cross-functional initiatives for Safety Science including SOPs and Procedural Documents. Builds cross functional relationships with SMT membership and stakeholders Leadership Behaviors Learner Seeks feedback and best practices for continued development Degree Requirements Scientific degree (eg, BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience. Experience Requirements Minimum of 3 - 5 years relevant Pharmacovigilance / Pharmaceutical Industry experience Key Competency Requirements Working understanding of medical concepts and some familiarity with safety activities in drug development and postmarketing and global safety health authority requirements. Working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills. Appropriately communicates items that could impact timelines or quality. Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism) Ability to work well in cross-functional teams. Good collaborative and communication skills with scientific subject matter. Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions. Understand aspects and methods for data analysis, interpretation and presentation. Possess good working skills in MS Word, Excel and PowerPoint, including statistics

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