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Product Surveillance Specialist Job
Date: Nov 10, 2009
Location: Rochester, NY, 14673, USA
Job Title:
Product Surveillance Specialist
Req #:
5321BR
Job Description:
Position Summary Manage product complaints, ensuring that they are accurately and thoroughly recorded, evaluated, investigated and closed in a timely manner. Position involves working closely with subsidiaries/customer service, analytical groups, complaint handling facilities, and manufacturing sites to coordinate complaint investigation activities. Investigating of adverse events, performing medical review, ensuring a reportability review is completed, and submission of required government reports within mandatory time frames. Manage product liability claims with the support of Legal and Risk Management, as required. Specific Job Duties ? Work closely with B&L subsidiaries, analytical groups, Global Quality, Global Regulatory, Site Quality, Medical Affairs, Law Department, and Manufacturing facilities, as necessary to resolve product complaints. ? As part of the complaint management process it will be necessary to frequently communicate with patients, retail accounts, hospitals, physicians and other health professionals in order to gather information relevant to the investigation and resolution of product complaints. ? Review medical records and/or event details associated with product complaints and determine the seriousness of the event. ? Ensure medical review and reportability review are completed timely for complaints that may be reportable to government agencies. ? Prepare and submit government reports within mandatory timeframes. For example, adverse event reports may be required to be submitted to the US FDA, Health Canada, and various European Competent Authorities. ? Manage product liability claims with the support of Law Department and Risk Management, as required. ? Receive and process product complaint samples and forward for appropriate evaluation. ? Review product evaluation results to assess whether the data is accurate, thorough, and appropriate as it relates to the complaint. ? Prepare concise, complete and informative written response to customers. ? When necessary, request the appropriate plant evaluation tasks. Provide support for non-conformance activities, such as plant investigations and field actions. ? Ensure timeliness of plant evaluation response. Review plant evaluation response for completeness. Follow up with site quality staff as necessary. ? Ensure that management is made aware of all unique and/or unusual events as they relate to product complaints. ? Review complaint files for closure, ensuring that they are in compliance with all relevant regulations and internal policies and procedures. ? Provide training and support to global locations involved in complaint handling activities working to ensure compliance with applicable procedures. ? Generate, review and distribute product complaint reports and ad hoc reports as requested.
Qualifications
? College degree required. ? Licensed, registered or certified to administer health care required. ? Regulatory, Quality experiences in the medical device industry a plus. Experience in Customer Service related activities preferred. ? Good communication, interpersonal and writing skills. Ability to organize and prioritize work effectively. Above average computer skills, and experience with Microsoft Word, Excel and Outlook.
Work Location NY - Rochester-1400 N Goodman Street Relocation Available No
Status Full-Time
Product Surveillance Specialist
Req #:
5321BR
Job Description:
Position Summary Manage product complaints, ensuring that they are accurately and thoroughly recorded, evaluated, investigated and closed in a timely manner. Position involves working closely with subsidiaries/customer service, analytical groups, complaint handling facilities, and manufacturing sites to coordinate complaint investigation activities. Investigating of adverse events, performing medical review, ensuring a reportability review is completed, and submission of required government reports within mandatory time frames. Manage product liability claims with the support of Legal and Risk Management, as required. Specific Job Duties ? Work closely with B&L subsidiaries, analytical groups, Global Quality, Global Regulatory, Site Quality, Medical Affairs, Law Department, and Manufacturing facilities, as necessary to resolve product complaints. ? As part of the complaint management process it will be necessary to frequently communicate with patients, retail accounts, hospitals, physicians and other health professionals in order to gather information relevant to the investigation and resolution of product complaints. ? Review medical records and/or event details associated with product complaints and determine the seriousness of the event. ? Ensure medical review and reportability review are completed timely for complaints that may be reportable to government agencies. ? Prepare and submit government reports within mandatory timeframes. For example, adverse event reports may be required to be submitted to the US FDA, Health Canada, and various European Competent Authorities. ? Manage product liability claims with the support of Law Department and Risk Management, as required. ? Receive and process product complaint samples and forward for appropriate evaluation. ? Review product evaluation results to assess whether the data is accurate, thorough, and appropriate as it relates to the complaint. ? Prepare concise, complete and informative written response to customers. ? When necessary, request the appropriate plant evaluation tasks. Provide support for non-conformance activities, such as plant investigations and field actions. ? Ensure timeliness of plant evaluation response. Review plant evaluation response for completeness. Follow up with site quality staff as necessary. ? Ensure that management is made aware of all unique and/or unusual events as they relate to product complaints. ? Review complaint files for closure, ensuring that they are in compliance with all relevant regulations and internal policies and procedures. ? Provide training and support to global locations involved in complaint handling activities working to ensure compliance with applicable procedures. ? Generate, review and distribute product complaint reports and ad hoc reports as requested.
Qualifications
? College degree required. ? Licensed, registered or certified to administer health care required. ? Regulatory, Quality experiences in the medical device industry a plus. Experience in Customer Service related activities preferred. ? Good communication, interpersonal and writing skills. Ability to organize and prioritize work effectively. Above average computer skills, and experience with Microsoft Word, Excel and Outlook.
Work Location NY - Rochester-1400 N Goodman Street Relocation Available No
Status Full-Time
Nearest Major Market: Rochester
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