Post Market Survelliance Analyst - Remote (Entry Level or 3 Years Exp)
Position : Post Market Survelliance Analyst Location : San Diego, CADuration : 12 MonthsTotal Hours/week : 40.001st ShiftClient : Medical Devices CompanyJob Category : Engineering/TechnicalLevel of Experience : Mid-LevelEmployment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)SummaryJob Description:The Post Market Surveillance Analyst will collaborate with a team of statisticians, engineers and analysts in support of post market surveillance processes.Responsibilities
- Conduct post market product data analysis and aid in creating necessary post market documentation such as post market surveillance plans and reports
- 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.
- Collaborates and interacts with internal teams, including teams representing Medical, R&D, Product Quality, Engineering and Supplier Quality. Regularly interacts with executive management.
- Reviews and continuously executes the post market surveillance process. Extracts monthly post market quality data and helps in update of PMS reports
- Performs post-market safety and surveillance activities including data analysis, tracking/trending and signal detection.
- Summarizes trends, signals, and escalations.
- Ensures appropriate identification and governance of complaint coding schemes. Links post-market quality systems to risk management files as appropriate.
- Completes projects/other duties as assigned. Provides support during external and internal audits of the post market surveillance processes.
- Excellent written and verbal communication skills
- Strong organizational skills, time management skills and ability to self-manage in a complex/ time sensitive environment
- Project management skills and the ability to maintain excellent electronic records
- Intermediate to advanced MS excel skills (Pivot tables, Vlookup, formulas).
- Ability to effectively collaborate with team members across functional areas
- Bachelor’s degree in mathematics, engineering, business or related field
- An advanced degree (MBA or MS) and a concentration in a technical, scientific, engineering or related field is preferred
- Minimum of 2 years of relevant business experience
- An understanding of basic statistical analysis software packages (SAS, R, SPSS, SQL) is preferred.
- A demonstrated analytical capability with the ability to summarize data into graphs, charts and statistics is required.
- Demonstrated ability to identify issues in post-market surveillance, complaints and service is preferred.
- Experience with analysis and signal detection in a large data set is preferred.
- Understanding of Risk Management is preferred.
- Prior experience in the medical device industry or an FDA regulated environment is preferred.
- Experience with Complaint Management System and technical documents is preferred.