Beena Devi Email & Phone Number

A seasoned strategic and thoughtful pharmaceutical industry professional with expertise across domains (PV, medical writing, medical data review, RWE) of clinical research industry. Have proven track record of project leadership capabilities, developing people, building customer relationship, problem solving abilities, managing end to end projects, consistent delivery of desired outcomes, collaboration with cross functional teams, creating credible business relationships, developing efficient delivery solutions, subject matter expertise, and mentoring capabilities.Provides strategic leadership support at account level. Acts as customer's primary point of contact for global and local deliverables comprising of multiple Lifecycle Safety functions. Collaborates in account management strategies and provides oversight of their implementation. Contributes to identification of new business opportunities, proposal development process, and strategic planning. Supports transforming customer relationships to partnership. Manages profitability for assigned projects. Supports process improvements to optimize the work processes. Acts as SME for safety processes for internal and external stakeholders. Contributes to strategic planning, supports in creative solutions and ongoing process improvements to meet anticipated future customer needs. Ensures that the audit results, and other critical issues are managed appropriately.Has wide experience in reviewing clinical and post marketing patient data from medical prospect, supported the clinical and safety teams with respect to safety study management, answering Inspection/Audit/ethics committee questions, submissions related questions, preparing summary reports, preparing study safety reports, writing and reviewing safety narratives, reviewing the patient profiles to review safety and efficacy parameters on the entire patient data, review patient data to identify any safety concerns and protocol deviations, writing and reviewing case safety narratives and lay summaries in post marketing set up, writing newsletters, evaluating individual case safety reports from medical, quality and regulatory oversight perspective for both drug and combination of drug device products. Have expertise in product labelling review and configurations. Have executed the project management activities at both account level and product level basis the requirement. Have good exposure of working in the therapeutic areas – endocrinology, oncology, cardiovascular, and central nervous systems.

Listed skills include Writing And Reviewing Subject Narratives, Handling Large Subject Narrative Projects Independently, Training New Hires On Narrative Writing, Performing Content Review Of Draft Clinical Study Reports, and 7 others.