Post market surveillance specialist
general responsibilities and duties:
1. develops professional expertise and applies company policies and procedures to resolve a variety of issues.
2. interfaces with customer service and customers/patients to gather additional information required for complaint initiation and investigations, including the retrieval of product samples or durable equipment for evaluation.
3. ensures that complaints from multiple sources (email, phone, verbal, fax, etc.) are entered into the complaint database.
4. receives, reviews, and enters data into the complaint management database regarding customer/patient product inquiries and complaints, following good documentation practices (gdp).
5. works on problems of moderate scope, analyzing situations or data by reviewing various factors. Exercises judgment within established procedures to determine appropriate actions.
6. ensures that durable equipment crm technical service reports are accurately identified for system transfer.
7. determines product and incident complaint codes based on the master symptom code severity list.
8. notifies customers upon receipt of product inquiries or complaints and provides preliminary support as needed.
9. prepares customer communications, such as response and acknowledgment letters.
10. collaborates with sales, marketing, and manufacturing departments to resolve product issues and provides feedback to customers.
11. reviews the timely coding of completed investigations, closes complaint files, and ensures all relevant information is documented consistently before closure.
12. performs data queries and ad hoc trend analyses on reported product problems and complaints.
13. interfaces with corporate quality engineering and manufacturing sites as needed for product investigations and trend analysis.
14. adheres to the fmcna compliance program, following all regulatory and company policies.
15. strives to meet an accuracy goal of 95%, ensuring data collection through routine business processes.
qualifications:
* bachelor's degree preferred, ideally in a healthcare-related field.
* experience in processing medical device or drug complaints is preferred.
* strong interpersonal skills.
* proficiency with industry-standard complaint management systems, crystal reports, ms access, and excel.
* familiarity with medical terminology is advantageous.
* fluent in english; bilingual in english/spanish is preferred.
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