- Develop and maintain a high quality and efficient adverse event intake, review and reporting structure for investigational and marketed products while adhering to governing standard operating procedures (SOPs), work instructions and applicable regulatory guidelines and regulations.

- Establish and maintain relevant SOPs and work instructions in support of the approved work flow and process.

- Ensure compliance with relevant SOPs, work instructions and systems.

- Develop and track metrics appropriate to a continuing quality and productivity assessment. Track and periodically report on all agreed upon department metrics.

- Participate in Business Development, Marketing and Sales activities.

- Establish and maintain an appropriate Pharmacovigilance office, with attendant procedures and processes.

- Oversee appropriate validation and revalidation of all process-related electronic systems.

- Monitor project time charges within the functional groups.

- Ensure currency with pertinent regulations and guidance documents.

- Lead continuous improvement of departmental processes and procedures.

- Establish and maintain an intellectually stimulating and friendly workplace environment, encouraging training to ensure currency, professional development, and scientific and medical exchange.

- Assist with global implementation and coordination of department operations to include processes, system implementation, business development and metrics reporting.

- Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.