Provides a safe clinical environment by managing safety practices and safety data collection; analyzing and disseminating safety information in post marketing and/or clinical trial areas; directing staff.
* Accomplishes clinical safety human resource strategies by determining accountabilities; communicating and enforcing values, policies, and procedures; implementing recruitment, selection, orientation, training, coaching, counseling, disciplinary, and communication programs; planning, monitoring, appraising, and reviewing job contributions; planning and reviewing compensation strategies.
* Develops clinical safety organizational strategies by contributing information, analysis, and recommendations to strategic thinking and direction; establishing functional objectives in line with organizational objectives.
* Establishes clinical safety operational strategies by evaluating trends; establishing critical measurements; determining production, productivity, quality, and customer-service strategies; designing systems; accumulating resources; resolving problems; implementing change.
* Develops clinical safety financial strategies by estimating, forecasting, and anticipating requirements, trends, and variances; aligning monetary resources; developing action plans; measuring and analyzing results; initiating corrective actions; minimizing the impact of variances.
* Completes investigations and provides information by interfacing with consumers and/or study sites; investigating clinical trial sites; investigating and preparing individual adverse event reports; helping with the preparation of periodic reports; completing special assignments.
* Provides a safe laboratory environment by applying concepts relevant to the pharmaceutical industry; enforcing domestic and international safety regulations.
* Controls adverse event data management system by controlling data collection, data entry, safety data analysis; directing internal distribution of safety data.
* Completes special projects by working in a matrixed environment; serving on ad hoc committees; identifying and implementing new technology and resources; redesigning systems; re-deploying human resources.
* Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
* Enhances clinical safety and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
Creating a Safe, Effective Environment, Clinical Skills, Trial Development, Biohazard Safety, Infection Control, Sterilization, GCP, Safety Management, FDA Health Regulations, Quality Management, Developing Standards