Penumbra, Inc. · 1 month ago
Senior Medical Affairs Safety Associate
United States
Full-time
Remote
Senior Level
$126K/yr - $194K/yr
6+ years expPenumbra is a global healthcare company focused on innovative therapies. They are seeking a Senior Medical Affairs Safety Associate to provide medical oversight and safety monitoring for clinical trials involving medical devices, ensuring participant safety and compliance with regulatory requirements.
Medical Device
Responsibilities
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
Qualification
Required
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
Benefits
Medical
Dental
Vision
Life
AD&D
Short and long-term disability insurance
401(k) with employer match
An employee stock purchase plan
Paid parental leave
Eleven paid company holidays per year
A minimum of fifteen days of accrued vacation per year, which increases with tenure
Paid sick time in compliance with applicable law(s)
Company
Penumbra, Inc.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies.
1001-5000 employees
H1B Sponsorship
Penumbra, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (36)
2024 (42)
2023 (46)
2022 (43)
2021 (36)
2020 (26)
Funding
Current Stage
Late StageLeadership Team
Adam Elsesser
CEO
Frances Palmer-Smith
Chief Trust Officer
Recent News
Med-Tech Innovation
2024-05-05
Company data provided by crunchbase