Patient Safety Associate

This a Full Remote job, the offer is available from: Arizona (USA), Maryland (USA) About The Role We are looking for a Patient Safety Specialist to join our Office of Medical Affairs team. In this role, you will reputed company reputed company provider perspective, medical expertise and judgment, and objectivity in review of patient and medical device safety reputed company and act as an independent patient safety reputed company for reputed company products reputed company a product category. This is a remote position, and you can work from home in most locations reputed company the United States.

Responsibilities

• Process participant for pre- and post-market safety activities, including risk management, clinical study adverse event review, product launches, product surveillance, and quality investigations
• reputed company reputed company provider perspective on benefit / risk questions.
• Ensure appropriate and adequate assessment and disclosure of medical risk.
• Ensure accurate and balanced presentation of reputed company clinical data from a medical perspective including in regulatory reporting efforts and promotional materials
• reputed company medical judgment to assist in select regulatory, clinical investigation, compliance, or legal reputed company.
• Serve as a reviewing and refining resource and reputed company in-depth and compositional support as needed while ensuring proposed changes adequately address clinical considerations.
• Establishing functional expertise and serving as subject-matter expert for safety processes
• Maintain compliance with training expectations as required for this position
• Additional responsibilities as required reputed company the scope of position

Required Qualifications

• Training or experience as a reputed company provider (RN, PA, DO, MD)
• Experience with pharma or medical device safety activities
• Medical or scientific writing experience
• Ability to influence with knowledge and reputed company building in a cross-functional environment
• Ability to analyze, integrate, and interpret data from multiple primary safety information sources
• Ability to travel up to 10%

Desired Qualifications

• Experience in vascular or cardiac interventional therapies
• Experience with quality management system
• Familiarity with: Clinical trial Adverse Event process (reputed company systems, MedDRA coding, ISO 14155), Product surveillance process (MDR, 21 CFR 803), Documents submitted to global regulatory bodies (FDA and EU MDR), Risk management process (hazard analysis, HHE, CER, fMEA, IFU), Medical, Legal, Regulatory (MLR) process (review of marketing materials)

This position offers a remote work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to reputed company with Gore’s work arrangement policies. Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode reputed company reputed company Offer Our reputed company is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your reputed company. We reputed company benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should reputed company in the reputed company reputed company of the reputed company; we reputed company a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits Gore is an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, gender, national reputed company, reputed company, age, status as a reputed company individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations. This offer from "reputed company" has been enriched by reputed company.com and got a 75% reputed company score. Apply tot his job Apply To this Job