Associate Complaint Handling

5 days ago

Singapore BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE. LTD. Full time

**Position Summary**

Management of Product Complaint & Patient Safety Incident Reporting, Global level

**Position Responsibilities**
- Lead and monitor complaint handling process and patient safety incident reporting till closure.
- Ensure complaints from all sources (clinical trials, post-marketing, literature and supplier) have timely and quality collection, processing, follow-up, analysis, and regulatory reporting according to standard, local & global medical device incident reporting requirement.
- Provide input to department policies and procedures and ensures their proper implementation; ensures that area's activities comply with any applicable legal and regulatory guidelines.
- Actively participate internal audits in collaboration with QA ensures appropriate and timely responses to findings coordinates complaint non-conformance and corrective action/preventive action (CAPA) plans, ensure appropriate root-cause analysis and documentation.
- Ensure that product safety signals from aggregate data are identified promptly and communicated/escalated appropriately to QA department’s head, including oversight (as appropriate) of use of signal detection and other sources for potential product signals.
- Maintain a close collaboration with global associates by proactively escalating potential quality/safety issues / changes that affect the risk-benefit profile of Biosensors products.
- Review and provide support for PSURs as a delegated activity, whenever required.
- Review license partner agreements with regard to Complaint & Patient Safety Incident activities.
- Provide medical opinion, i.e. evaluate the complaint in terms of medical understanding, whenever necessary.
- Timely completion of Incident Report to RA and license partners.
- Communicate evidence with fair balance, in accordance with company, standard, global and local regulatory standards whenever necessary.
- Respond to customer on investigation outcome by drafting and issuing reply letters.
- Perform final reportability assessment of individual complaint report.
- Lead complaint and incident reporting analysis review
- monthly and quarterly.
- Translates complaint related documents, as per competency.
- Monitor monthly metrics and add workflow improvements to ensure quality and timeliness.
- Liaise cross-functionally to deliver comprehensive strategies that impact the entire facility.
- Involves some straightforward enquiries around company products, both externally from healthcare professionals and internally.
- Ensure that the performance of direct report is proactively managed and that they are coached, trained and developed to maximize their contributions. Enhance scientific and clinical experience of staff through training and coaching.
- Accountable for the delivery of high quality, timely and standardized safety deliverables, and provides content guidance and approval, as needed.
- Provide effective guidance to complaint handling team: Responsible for supervising and managing complaint handling team on a daily basis. Being a contact point for all team members. Proactively act to ensure smooth team operations and effective collaboration / create an inspiring team environment with an open communication culture.
- Set clear delegate tasks and set deadlines / oversee day-to-day operation.
- Give occasional presentations on the complaint department performance.
- All other Adhoc assignments as required.

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