Senior Medical Affairs Safety Associate

This is a senior position in Clinical Research under the supervision of the Senior Manager of Medical Affairs. The Sr Medical Affairs Safety Associate provides medical oversight and safety monitoring for clinical trials involving medical devices. This role ensures participant safety, compliance with regulatory requirements, and integrity of trial data.

•Monitor participant safety throughout the clinical study by reviewing adverse events (AEs) and serious adverse events (SEAs). *

•Review clinical data for safety signals and trends. *

•Evaluate events for unanticipated adverse device effects per FDA and ICH-GCP guidelines.

•Identifies and escalates safety concerns to appropriate stakeholders.

•Provide input into the design and preparation of clinical studies for investigations sponsored by Penumbra. These include but are not limited to protocol design, case report form (CRF) development, and drafting of patient risk documents. *

•Report adverse events to regulatory agencies as required per country specific regulations

•Review published literature for adverse events and off label use. *

•Ensure adherence to ICH-GCP, FDA, EU MDR, and other applicable regulations for adverse events reporting. *

•Assist in the reconciliation of adverse events (AEs) in clinical trials with post-market reporting. *

•Participate in Clinical Trial Team meetings providing safety updates and addressing safety issues arising in assigned clinical studies. *

•Develop Safety plan and appropriate Charters for studies*

•Review published literature for generation of safety thresholds. *

•Oversee collection, and transfer for safety data, imaging to the safety committees. *

•Review data validation reports, listings ensuring clinical data integrity is maintained.*

•Write narratives for adjudication by independent medical reviewers. *

•Complete safety narratives for regulatory reporting as required.

•Coordinates scheduling, logistics, and documentation for committee meetings.

•Ensure timely preparation and delivery of events for CEC and DSMB. *

•Serves as a primary safety liaison on Clinical Study core team, committee members or CROs as applicable. *

•Authors safety documents including Clinical Study Safety Plan, CEC/DSMB documents, etc. as applicable.

•Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *

•Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *

•Ensure other members of the department follow the QMS, regulations, standards, and procedures. *

•Perform other work-related duties as assigned.

•Bachelor’s degree in Public Health, Nursing, Medicine, or related discipline with 6+ years of experience in medical monitoring, clinical/scientific research, or nursing, with strong knowledge of clinical trial safety processes, regulatory requirements, and data handling, or an equivalent combination of demonstrated performance, education, and experience.

•2+ years of medical device and safety operations experience.

•Familiarity with electronic data capture (EDC) systems and imaging platforms.

•Experience with MedDRA coding and SAE adjudication processes.

•Knowledge of ICH-GCP, FDA and EU regulations.

•High level of competency with Microsoft Office applications including Word & Excel.

•Excellent verbal and written communication skills.

•Excellent organization, communication, and stakeholder management skills.

•Excellent attention to detail and problem-solving skills.

•General office environment.

•Willingness and ability to work on site.

•May have business travel from 0% - 10%.

•Requires some lifting and moving of up to 10 pounds.

•Must be able to move between buildings and floors.

•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.

•Must be able to read, prepare emails, and produce documents and spreadsheets.

•Must be able to move within the office and access file cabinets or supplies, as needed.

•Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.