The Product Surveillance Coordinator II role contributes to the process of timely, high quality and consistent product complaints management, including appropriate identification and response to risks, adverse event reporting decisions, and collection and documentation of complaints.
Duties & Responsibilities
Set up and manage product complaints in the global complaints database to ensure complaints are managed according to regulatory requirements and customer expectations.
Communicate with customers, Affiliates and internal departments regarding product complaints and document the complaint file.
Use judgment to analyze adverse event information and determine if events are reportable to regulators.
Review the product complaint investigation results and prepare a letter for the customer synthesizing the investigation results.
Provide back-up support for receiving product sample; documenting complaint file with sample receipt information; and routing product samples.
Actively engage in continual process improvements to the global complaints management process to meet customer and regulatory expectations.
Provide active support for the product complaints phone line.
Provide back-up support for global complaints email inbox.
Escalate relevant product complaint issues, as necessary.
Actively participate in training and professional development.
Other duties as assigned, according to the changing needs of the business.
This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
Technical Knowledge and Skills :
BS / BA degree is strongly preferred.
University Degree (BA degree) preferred.
Ability to use standard office equipment such as, but not limited to, copier, fax, scanner, telephone, and headset.
Knowledge of and expertise in the use of personal computers for spreadsheets (Excel), communication and scheduling (Outlook), word processing (Word), and various databases (Oracle, SharePoint).
Prefer at least 1 year of general office experience involving independent decision making and prioritization of multiple tasks.
Ability to apply knowledge of regulatory requirements to product complaints management.
Ability to develop effective working relationships and participate effectively on project teams with cross-functional groups.
Ability to understand and gather the information necessary for investigation of product complaints and adverse event reporting.
Ability to establish and manage multiple priorities simultaneously while meeting deadlines.
Very high attention to detail.
Ability to work independently with minimal supervision.
Ability to maintain confidentiality of product complaint information. A working knowledge of the HIPAA privacy regulation is necessary.
Application of knowledge of universal precautions associated with the OSHA Bloodborne Pathogen standard as it relates to job duties.
Excellent customer relation skills.
Accurate and professional verbal and written communication skills.
Smiths is always looking for curious minds. For new colleagues who want responsibility and relish a challenge. Those who would like to use their talents to help make the world safer, healthier, more efficient and more connected.
We're proud that we've been helping propel the human world forwards during our 160 year history of innovation. By looking at things differently.
By adapting and never standing still. And by always thinking big.
Today we're an aligned global business of five divisions and around 22,000 colleagues, that touches the lives of millions every year across five vibrant global markets.
In Smiths Medical, one of the five divisions of Smiths Group, we touch the lives of millions of people every day. Our colleagues are focused on providing innovative, lifesaving solutions for patients around the world.
So whether you're an experienced professional or just starting out on your career, our global scale and focus on growth means great career opportunities for the right colleagues.
There's never been a better time to join Smiths. And help us create the future.