Employment

Title of Position:  Product Safety Specialist

Job Code # 08024

Location:  Rockville, MD

Applicants must meet the following requirements:

• Bachelor of Science in Nursing or equivalent medical degree.
• Current professional licensure in the United States.
• At least 3 years of clinical experience in a patient care setting.
• At least 5 years of clinical trials drug safety experience in industry or equivalent experience.
• Excellent oral and written communication skills ability to effectively represent Product Safety in meetings and interact with managers in other departments to complete tasks and resolve issues; experience with medical writing and summarization of clinical safety information is required.
• Ability to manage several high-priority activities within required timelines.
• Ability to manage people and processes to meet corporate objectives.
• Ability to work independently with minimal supervision, but seek appropriate involvement from senior management regarding complex issues beyond position scope.
• Solid knowledge of applicable domestic and international safety reporting requirements.
• Intermediate to advanced-level computer skills including word processing and safety database management.

The selected candidate will be responsible for:

• Management of CRO safety staff as appropriate to ensure that safety-related project milestones are met within required timelines.
• Coordination of safety review committees including preparation of data, documentation of outcomes and timely completion of activities based upon safety review committee recommendations.
• Management of serious adverse event reporting system including medical and safety evaluation of serious cases in collaboration with the Medical Monitor, ensuring complete case information and attainment of event outcome, safety reporting, data entry and maintenance of cases in safety database, development of safety data collection forms and tracking reports, reconciliations of serious adverse events between the safety and clinical study databases, and summarization of serious cases for safety review committees, regulatory authorities and business partners.
• Participation in call schedule as a first responder for safety issues after hours, including weekends and holidays.
• Keeping current regarding proposed changes to domestic and international safety reporting requirements and making required changes to processes and systems.
• Participate in the development of product Risk Management Plans (RMPs)
• Participation in the selection, development, validation, implementation, and training of safety software and other process systems in collaboration with managers from appropriate departments.
• Development of standard operating procedures for core safety surveillance processes.
• Maintenance of safety files and documentation that are compatible with the corporate document management system.
• Review of product and class safety information including pre-clinical, clinical and post-marketing data from internal and external sources.
• Function as a Product Safety representative at corporate management meetings as appropriate.
• Ensure communications with other parts of the organization regarding product safety risk management and compliance. 

Benefits:  Competitive salary and benefits package

Qualified applicants with current permission to work in the United States, please send your resume and salary history to:

Human Resources 
MacroGenics, Inc.
1500 East Gude Drive
Rockville, MD 20850
E-mail:  HResources@macrogenics.com