My responsibilities: 3 years of authoring and contributing to numerous aggregate safety reports including PADERs, and PSURs as well as a variety of clinical safety documents including safety management plans and safety date for clinical reports; Supervise workflow of staff in the pharmacovigilance department for both post-marketing and clinical studies; Client interaction including addressing client questions and client notifications; Schedule and conduct Pharmacovigilance training for call center, medical information and pharmacovigilance staff; Participate in development and continuous improvement of processes and workflow including SOPs, task descriptions, narrative templates, coding and assessment conventions and job descriptions.
My Responsibilities: Call intake for pharmaceutical, dietary supplement and medical device products for both adverse event and product complaint reporting; Pharmacovigilance case processing including: Case assessment; Case follow-up activities and MedWatch preparation; Developed training materials, conducted training presentations and on-the-job-training for pharmacovigilance staff; Worked on transition team for safety database transfer from AERS to Argus, also familiar with the IRMS database.
My Responsibilities: Managed health and safety calls, medical information requests and product complaints by either providing product information to consumers, end users and healthcare professionals or documenting their adverse event reports; Completely and accurately documented calls; Managed toxicology calls by providing consumers with safety information and treatment advice following exposure to products.
My Responsibilities: Managed multiple cross-functional development team's budgets, timelines and deliverables including achieving regulatory approval of a number of pharmaceutical products.
My Responsibilities: Project leader for a drug-coated medical device development project; Coordinated manufacturing, testing and release activities for supplying the ongoing Phase II Clinical study of the device, including project plan creation, regular budget reviews, contingency planning and risk analysis.
My Responsibilities: Acted as Project Leader for a Phase II/III biological development product; Accountable for the timely completion of biologic manufacturing and testing activities (per GMP and GLP) required for release of the product for investigational use; Worked with the clinical and regulatory groups to coordinate manufacturing, packaging and shipping of clinical supplies and CMC documentation for regulatory approvals; Managed direct reports including annual reviews and performance appraisals.
My Responsibilities: Managed project management personnel, activities and budgets to meet business goals and financial targets; Coordinated regular project updates for management, including progress and budget reports; Developed training materials and conducted training presentations for project management staff and project team members; Acted as a liaison between Business Development and Project Management in facilitating the initiation of new development projects; Conducted due diligence, contract development and strategic portfolio planning.
My Responsibilities: Managed multiple cross-functional development team's budgets, timelines and deliverables including achieving regulatory approval of a number of pharmaceutical products; Trained team members, project assistants and project leaders on project management basics, communication and PM tools.
My Responsibilities: Monitored the conduct of clinical studies, Phase I and II, as required for FDA approval of pharmaceutical products; Initiated clinical study protocols and reviewed all study reports, safety management plans and contracts; Responsible for supplying all required clinical documentation for regulatory submission; Ensured that all clinical work was conducted according to GCPs; Served as a clinical representative on multiple cross-functional project teams charged with developing new pharmaceutical products.
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