This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Senior Clinical Safety Specialist is responsible for supporting the clinical safety strategy, oversight, and management of safety-related activities for the company's medical device portfolio. This role ensures compliance with global safety regulations and standards, provides scientific and clinical safety expertise throughout product development and post-market phases, and supports risk management activities in collaboration with cross-functional teams. - Serve as a clinical safety expert for assigned medical devices throughout the product lifecycle — from development through post-market surveillance. - Support in the development, implementation, and maintenance of clinical safety governance frameworks, policies, and procedures. - Support clinical safety review boards and safety data evaluations in collaboration with clinical, regulatory, and quality teams. - Oversee identification, evaluation, and communication of safety signals from clinical trials, post-market data, and literature. - Support preparation and review of clinical safety deliverables (e.g., safety narratives, adverse event summaries, safety sections of clinical study reports). - Partner with Regulatory and Quality Assurance to support device risk management files, benefit-risk assessments, and periodic safety updates. - Support vigilance reporting and field safety corrective actions (FSCAs) as needed. - Collaborate with other Clinical Affairs members, R&D, Quality, and Regulatory teams to ensure clinical safety considerations are integrated into product design and development. - Provide input to clinical study protocols, informed consent forms, and investigator training related to safety. - Participate in regulatory submissions (e.g., IDEs, PMAs, 510(k)s, MDRs, CE marking, etc.) ensuring safety content is complete and accurate. - Ensure all safety activities comply with applicable global regulations (e.g., FDA, ISO 14155, MDR, EU-MDR Article 2(58), MDCG2020-10/1, ISO 14971). - Monitor and interpret evolving safety regulations and standards to ensure proactive compliance. - Drive continuous improvement initiatives in safety systems, processes, and reporting. - Other duties as assigned. Qualifications - Bachelor’s degree in relevant area of study. - Minimum of 5 years experience in the medical device industry, including experience with clinical safety or risk management. - Experience with medical device safety reporting requirements (e.g., MDR, FDA, ISO 14155/14971) essential. - Demonstrated experience in both pre-market and post-market safety activities, strongly preferred. - Strong understanding of global safety regulations and quality management systems. - Excellent analytical and clinical judgment skills. - Ability to synthesize complex clinical data and communicate clearly to technical and non-technical audiences. - Strong project management skills. - Exceptional written and verbal communication abilities. Benefits - Comprehensive benefits package for full-time employees. - Health, dental, and vision insurance. - Life, short-term and long-term disability insurance. - 401(k). - Paid time off. - And more.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This role involves supporting live cardiology visits in a fully remote telehealth environment. - No physical rooming or exam room turnover - No hospital shifts - Structured, documentation-heavy role - Remote position — Eastern Time Zone preferred - Hybrid flexibility available for candidates local to Columbia, MD - Full-Time | Monday–Friday | 7:30am–4:00pm EST - Compensation: $18–$24 per hour depending on experience and location If you're an experienced MA who enjoys patient interaction but prefers a focused, virtual workflow without in-clinic chaos, this role offers that balance. You'll support cardiology providers during live telehealth visits in real time. - Virtually room cardiology patients - Guide patients through video visits - Collect cardiac history and reconcile medications - Document visits live in EMR - Manage same-day portal messages - Coordinate labs and follow-ups - Support structured telehealth workflows - No hands-on patient contact; all support is virtual Qualifications - Active Medical Assistant certification - 2+ years clinical MA experience - Telehealth visit support experience required - Strong EMR documentation skills - High-volume outpatient clinic experience - Reliable high-speed internet and dedicated remote workspace - Availability during 7:30am–4:00pm EST Requirements - Direct telehealth visit support experience - Confidence and professionalism on video - Ability to thrive in high-volume clinic environments - Cardiology experience or internal medicine with cardiac overlap - Ability to operate independently with minimal ramp-up Benefits - $18–$24 per hour depending on experience and location - Medical, dental, vision - 401(k) - PTO + paid holidays - Growth into Lead MA possible - Stable, investor-backed organization Work Environment - Fully remote (Eastern Time Zone preferred) - Hybrid option for candidates local to Columbia, MD - Monday–Friday only - 7:30am–4:00pm EST - No physical patient contact Growth & Environment - Structured cardiology-focused organization - Clear workflows and expectations - Growth into Lead MA possible - Long-term opportunity within telehealth cardiology - Exposure to workflows that support future nursing pathways - Internal nurse hiring creates post-graduation mobility - Real cardiology experience in a structured virtual model - Clear processes and expectations - Room to grow if you earn it

• Assists in development and maintenance of an efficient UM program to meet the needs of health plan members commensurate with company values. • Perform clinical reviews (i.e., part A, B, appeals, quality of care) and conduct peer to peer discussions. • Participate in inter-rater reliability activities. • Participate in analysis of utilization data and suggest improvement opportunities. • Provide appropriate mentoring and leadership to clinical teams as well as develop relationships to support growth and fiscal responsibility. • Participate in committees and workgroups to achieve department and corporate objectives. • Provide clinical support and participate in utilization management, quality management, clinical services and care management programs to identify opportunities for improvement and efficiency. • Serves as a clinical resource and subject matter expert to both clinical and non-clinical staff throughout the Devoted Health Plan. • Active participation in acute and post acute clinical rounds. • Conduct discussions with physicians in the Devoted network regarding: medical policies, utilization management, use of resources, and quality.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description Join IQVIA’s Sponsor-Dedicated FSP team and help advance healthcare through real-world evidence. In this role, you’ll work closely with one sponsor, gaining deep knowledge of their therapies while leveraging IQVIA’s global expertise. - Provides scientific and strategic leadership for RWE/Epidemiology studies - Serves as the primary lead for assigned studies or scientific workstreams - Ensures scientific rigor and operational feasibility of studies - Drives high-complexity deliverables such as protocols, publications, and analyses - May represent the sponsor in scientific discussions with vendors and external stakeholders Organizational Relationships - Reports to the sponsor’s RWE/Epidemiology Lead within their Integrated Evidence Generation (IEG) organization - Collaborates with Medical Evidence Development (MED) colleagues, CMO colleagues, Clinicians, HV&E/GAV, and other cross-functional scientific partners - Interfaces with other external vendors supporting study design and execution Responsibilities Scientific Expertise - Serves as a subject matter expert in epidemiology or related field - Provides strategic guidance on scientific approach and analytical methodologies - Leads development of scientific deliverables (e.g., study concepts, study protocols, statistical analysis plan, etc.) - Ensures quality and scientific integrity across all outputs - Conducts and oversees literature reviews - Supports real world data assessment and landscape evaluation - Responds to rapid epidemiological requests, including safety questions and information requests Study Execution Oversight - Provides input on study feasibility and resource needs - Leads scientific oversight of study execution, in collaboration with MED Evidence Generation Ops teams and external vendors - Ensures quality review and contributes to inspection/audit readiness for RWE/Epi studies - Performs/oversees code lookup and data QC tasks - Performs other relevant tasks as needed to support study execution Requirements - PhD in Epidemiology or related field preferred - Master’s with significant experience in rare exceptions - Experience designing and/or leading RWE/Epidemiology studies preferred - Experience designing study protocols, research reports, and/or publications preferred - Experience working in a matrixed, cross-functional team environment preferred Skills - Deep expertise in epidemiologic methods - Strong verbal and written communication skills - Strong organizational skills and project management capability - Ability to work effectively in a cross-functional environment - Ability to collaborate with analysts/programmers to ensure execution of analysis plans Benefits - Be part of a forward-thinking team that helps shape the next generation of evidence-based healthcare - Work hand-in-hand with one leading sponsor, gaining deep expertise in their therapies - Access IQVIA’s global network who supports your growth - This is your chance to make an impact, while building a career that matters Company Description IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.