Sr. Clinical Safety Scientist (Santa Barbara)

The Medical Safety Physician (MSP) is independently responsible for the proactive safety strategy and all medical safety aspects of a medical device including medical risk management for assigned development of marketed products and clinical studies.

The MSP monitors and manages the ongoing safety profile of devices to maximize the understanding of risks and benefits for consumers and study subjects through proactive review of all relevant pre- and post-marketing safety data, medical analysis and decision making.

Activities include the oversight of the safety aspects for clinical studies, development and maintenance of the Safety Information, development of ad hoc aggregate safety reports, contribution to and review of aggregate safety reports, development and conduct of signal detection activities and reports, safety sections of risk management plans, and assessment of individual case safety reports.

The MSP leads the Medical Safety Team relevant to the assigned products to determine and advise the course of action necessary to meet the safety goals and objectives of specific products and projects.

The MSP works in close collaboration with cross-functional teams and counterparts in regulatory labeling, clinical development, pre-clinical, manufacturing/quality, product support, and other functional areas to identify, evaluate, and communicate safety issues.

The MSP represents Allergan Medical in outside discussions or medical-scientific forums during Investigator Meetings, at regulatory agency meetings, and establishes and maintains a strong network within the organization.

Other activities, special projects and assignments may be given as required. As a result, the percentage of time spent across roles for which the employee is responsible for or assisting with will vary depending on product and project assignments, current development projects and requirements within the organization.

The MSP must conduct their work activities in compliance with all relevant global regulations, guidelines as well as all Allergan policies, and standard operating procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policy requirements and objectives.