Post Market Survelliance Analyst - Remote (Entry Level or 3 Years Exp)
<strong>Position : Post Market Survelliance Analyst <br><br></strong><strong>Location : San Diego, CA<br><br></strong><strong>Duration : 12 Months<br><br></strong><strong>Total Hours/week : 40.00<br><br></strong><strong>1st Shift<br><br></strong><strong>Client : Medical Devices Company<br><br></strong><strong>Job Category : Engineering/Technical<br><br></strong><strong>Level of Experience : Mid-Level<br><br></strong><strong>Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)<br><br></strong><strong>Summary<br><br></strong><strong>Job Description:<br><br></strong>The Post Market Surveillance Analyst will collaborate with a team of statisticians, engineers and analysts in support of post market surveillance processes.<br><br><strong>Responsibilities<br><br></strong><ul><li>Conduct post market product data analysis and aid in creating necessary post market documentation such as post market surveillance plans and reports</li><li>Ensuring the adequacy of the documentation of post market surveillance activities in terms of regulatory compliance and technical/statistical soundness, presents results and proposes escalations, corrective, and preventative actions as required.</li><li>Collaborates and interacts with internal teams, including teams representing Medical, R&D, Product Quality, Engineering and Supplier Quality. Regularly interacts with executive management.</li><li>Reviews and continuously executes the post market surveillance process. Extracts monthly post market quality data and helps in update of PMS reports</li><li>Performs post-market safety and surveillance activities including data analysis, tracking/trending and signal detection.</li><li>Summarizes trends, signals, and escalations.</li><li>Ensures appropriate identification and governance of complaint coding schemes. Links post-market quality systems to risk management files as appropriate.</li><li>Completes projects/other duties as assigned. Provides support during external and internal audits of the post market surveillance processes.<br><br></li></ul><strong>Skills And Competencies<br><br></strong><ul><li>Excellent written and verbal communication skills</li><li>Strong organizational skills, time management skills and ability to self-manage in a complex/ time sensitive environment</li><li>Project management skills and the ability to maintain excellent electronic records</li><li>Intermediate to advanced MS excel skills (Pivot tables, Vlookup, formulas).</li><li>Ability to effectively collaborate with team members across functional areas<br><br></li></ul><strong>Qualifications And Experience<br><br></strong><ul><li>Bachelor’s degree in mathematics, engineering, business or related field</li><li>An advanced degree (MBA or MS) and a concentration in a technical, scientific, engineering or related field is preferred</li><li>Minimum of 2 years of relevant business experience</li><li>An understanding of basic statistical analysis software packages (SAS, R, SPSS, SQL) is preferred.</li><li>A demonstrated analytical capability with the ability to summarize data into graphs, charts and statistics is required.</li><li>Demonstrated ability to identify issues in post-market surveillance, complaints and service is preferred.</li><li>Experience with analysis and signal detection in a large data set is preferred.</li><li>Understanding of Risk Management is preferred.</li><li>Prior experience in the medical device industry or an FDA regulated environment is preferred.</li><li>Experience with Complaint Management System and technical documents is preferred.</li></ul>
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