Directly responsible for ensuring that adverse events are processed, analyzed and reported according to Corporate SOP's, localWorking Instructions and local regulatory requirements. Responsible for distribution and retrieval of data to internal and external customers as needed for analysis and compliance with regulations. Serve as point of contact with clinical team in areas of adverse event process. Actively participate on the Investigator-Initiated Study (IIS) Review Committee to review Investigator Initiated Study proposals and provide input from a drug safety perspective. Prepare responses to regulatory authorities based on requests for information. Worked as lead on a project to remediate and restructure a local operating unit's pharmacovigilance program.

- direct drug information activities and medical product support for all FDA approved Roxane drug products- manage all safety surveillance activities for all approved drug products- oversee all regulatory aspects relating to the promotion and advertising of Roxane products- responsible for all labeling activities from design/development, submission, approval to maintenance for FDA approved drug products

- responsible for all graphic arts activities - design and development of all printed packaging materials (e.g., labels, leaflets, cartons, foils, etc.)- oversee all safety surveillance activities for all approved Roxane drug products- direct drug information activities and product support for all Roxane drug products

- responsible for all regulatory activities relating to Investigational New Drugs and New Drug Applications for Roxane Laboratories, coordinating the creation and submission of regulatory documents to the FDA- oversee all safety surveillance activities for domestic and international drug products- direct drug information activities and product support for all Roxane drug products

- oversee all regulatory aspects relating to the promotion and advertising of Roxane products, collaborate on multidisciplinary team, act as liaison between Roxane and FDA- responsible for all labeling activities from design/development, submission, approval to maintenance- responsible for safety reporting and product information/complaints for Roxane products- act as a regulatory liaison between Roxane and the FDA for INDs and NDAs

- responsible for the management and coordination of clinical research programs for the development of new drugs and dosage forms- oversee all aspects of drug development including FDA meetings, clinical development plans, protocol development, study management, and data preparation for regulatory submission- manage activities of contract research organizations used in drug development process- answer drug information questions related to Roxane products

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- direct the operation and coordination of progressive inpatient pharmacy services in a large, university-affiliated tertiary care pediatric hospital- coordinate the professional practice of 33 FTE pharmacists, technicians, and interns- coordinate and assist with the financial, personnel, operational, teaching, research, and clinical management functions throughout the department- member of Ohio State University Institutional Review Board (IRB)

- facilitate the pharmacy management of over 350 research protocols throughout the medical complex- assist in developing, implementing, maintaining, and assuming responsibility for procedures regarding proper control/handling of investigational drugs- aid sponsors, investigators and the institution in complying with regulatory requirements- member of Ohio State University Institutional Review Board (IRB)

- responsible for the daily operations and fiscal aspects of several ambulatory pharmacy sites throughout the medical complex- coordinated the professional practice of 24 FTE pharmacists, technicians, and interns- responsible for establishing and promoting clinical pharmacy services in the ambulatory arena