Job Description

Role Purpose

The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs

P͏ersonal Responsibilities

• Receives customer Complaints through calls/emails/faxes
• Assesses Complaints (events) for proposed MDR reportability and submits assessment to client
• Follow-ups for additional information and product returns
• Primary, single source customer contact
• Responsible for gathering event registration information (as defined by SOP’s) from customers
• Owns and manages the event through registration through potential regulatory reporting, sample retrieval, investigation, provide customer response and ultimately to closure/reopening as needed
• Responsible for contacting SME’s, QAs, Team Lead as needed to obtain complaint closure
• Responsible in timely escalation of significant events to the Team Lead
• Keeps oneself updated, aware of, and compliant to all Company policies and procedures which include Information Security Management Systems
• Keeps all company information which includes customer information confidential and secured
• Performs reviews and assessments of complaints processed by peers as part of cross utilization approach

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• · Day-to-day complaint management of complaint records, including intake, follow up, triage and entry, in accordance with local and international regulations, guidelines, and applicable directives.

  · Receipt of initial complaint from any source (external and internal) and ensuring all information/data is accurately captured at point of contact.

  · Responding to all inbound calls regarding complaints. For any inquiries or issues that do not pertain to complaints, escalate them according to the established escalation procedures.

  · Maintaining an understanding of information/data required to be collected for technical and adverse events/ reportable complaints to ensure compliance with regulations and directives.

  · Reviewing complaint data, assessing against reporting requirements and escalating for additional potential safety evaluation.

  · Performing intake / follow up / data entry activities and attaching corresponding source documents in a timely manner in a high volume, fast paced setting per requirements and directives.

  · Reviewing record documentation and follow-up activities for completeness and timeliness. Closing files according to established guidelines to meet required timelines.

  · Maintaining a working knowledge of company policies and procedures, departmental processes, and associated procedures and work instructions, Philips IGT devices for IFUs, Manuals, Promotional Material; coronary and therapeutic procedures.

  · Informing management of potential safety issues, emerging trends and/or concerns.

  · Performs reviews and assessments of complaints processed by peers as part of cross utilization approach.

  · Responsible for contacting SME’s, QAs, Team Lead as needed to obtain complaint closure.

  · Responsible in timely escalation of significant events to the Team Lead

  · Keeps oneself updated, aware of, and compliant to all Company and Customer policies and procedures, departmental processes, especially to associated procedures and work instructions relevant to the role

  · Keeps all company information, which includes customer information, confidential and secured.

S͏kills Required

· Able to write effective Medical and Technical narratives regarding the complaints

· Able to create Customer Letters

· Must have good computer skills, effective keyboarding skills

· Must have excellent telephonic and listening skills

· Able to think critically to determine the type of questions which need to be asked to

gather necessary information

· Good problem solving and analytical skills

· Good customer service skills

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Deliver