Responsible for day-to-day case management of quality technical and adverse event (AE) complaint records, including intake, acknowledgement, follow up, triage, system entry and final response, involving Alcon devices, pharmaceutical products, over-the-counter products. Complaint handling accountabilities reflect activities required to comply with local and international regulations, guidelines and applicable directives.
Responsible for day-to-day case management of unsolicited medical inquiries from eye care professionals (ECP), consumers and internal partners, including intake, acknowledgement, follow up, documentation, development and provisions of responses involving Alcon devices, pharmaceutical products, over-the-counter products.
Triage requests appropriately and document interactions directly into the approved department medical information repository/ database.
Major Accountabilities :
a.Receive initial complaint from any source (e.g. ECP, patients, internal/ external Alcon representatives) and assure all information/ data is accurately captured at point of contact.
b.Maintain an understanding of information/ data required to be collected for technical and AE complaints to assure compliance with regulations and directives.
c.Manage technical and AE complaint records for assigned area(s) using designated safety system(s).
d.Review potential complaint data received via safety system(s) and other methods, as required.
e.Is cognizant of, and works efficiently within applicable time zones.
f. Performs all necessary reconciliation activities including for all customer oriented programs in accordance with procedures.
g.Triage/ address calls from all sources for quality technical complaint, AE, requests for refund/ replacement product and credit.
h.Adheres to required metrics for all complaint handling responsibilities.
i. Arrange for replacement, product return and shipping of samples to QA sites for analysis.
j. Closes files according to established guidelines to meet required timelines.
k. Maintain a working knowledge of:
- Company policies and procedures, departmental processes, and associated work instructions.
- Evolving local and international regulations, guidelines and applicable directives.
- Alcon products for assigned therapeutics area(s) and corresponding documentation
- (Product Inserts, Direction for Use (DFU), Manuals, Promotional Materials).
- Eye anatomy, common diseases, ophthalmic procedures, terminology.
- Complaint management system, safety database and reporting tools.
- Informs management of potential safety issues, emerging trends and/or concerns.
l. Ensure that a business continuity plan is in place which is aimed at guarantee the uninterrupted availability of key vigilance processes and activities, or mitigate the impact of an unwanted event by means of measures and procedures enabling efficient and effective business resumption and/ or recovery, exists and has been tested accordingly.2. Responds to unsolicited medical and technical product inquiries from external and internal customers and assigns highest priority to customer satisfaction. Responsible for day-to-day case management of inquiries, including intake, acknowledgement, follow up, system entry, development and provision of responses involving Alcon devices, pharmaceutical products and over-the-counter products.3. Support the review and approval of Customer Oriented Program (COMP), collaborate with Marketing Program Owner (MPO) to define acceptable wordings for COMP related survey, questionnaires or responses to minimize potential data entry risks, ensure COMP reconciliation monitoring and MPO training in place.4. Support, collaborate and review of handling and reporting of safety information in clinical study.5. Support and collaborate in safety vendor monitoring, monitor vendor’s working process to ensure safety reporting meet the Country regulations. Work with safety vendor to ensure all required Vigilance Clause/ Safety Data Exchange Agreement/ Pharmacovigilance Agreement are in place appropriately and up-to-date. Ensure and oversight of safety vendor perform vigilance training to Alcon representative on a timely manner. Ensure potential gaps and problems are solved timely and mitigate impact, as applicable.6. Being aware of local medical device and pharmacovigilance legislation/ guidance in the Country of responsibility. Inform regional/ global of any changes of the local device and safety legislation in a timely manner.7. Support, collaborate and ensure Country inspection readiness. Support for and close out of audits, corrective plan, investigation and health authority inspections related to vigilance. Proactive identify compliance issues and compliance gaps, follow up and closure of observations in close cooperation with regional and global.8. Manage and maintain efficient vigilance filing and archive system. Ensure compliance to local data privacy law, if applicable. Ensure all vigilance procedures, organization charts, curriculum vitae, training records documentation are accurate, current and appropriately archived.9. Support QA organization task and activities, e.g. handle customer enquiry on device, pharmaceutical products, and over-the-counter products. Maintain complaint analysis regularly.
- Comprehensive understanding of national and international regulations for medical device vigilance and pharmacovigilance, medical terminology
- Highly motivated with interest in medical device vigilance and pharmacovigilance
- Excellent communications, interpersonal, people management skills, negotiation skills, strong team-working
- Quality and focus oriented; ability to work effectively and collaboratively across the organization and cross-functionally
- Computer skills
- Proactive, accountability and results-oriented
- Additional educational requirements as may be mandated by national requirements
- University degree in scientific discipline
- Ophthalmology/ Eye care experience desirable
- Experience working within multinational pharma companies or medical device
- Company desirable
Fluent in both written and spoken English and Mandarin so to support our Mandarin speaking countries in APAC (Preferably someone who speak, write and read Traditional Chinese)
Here at Alcon we are passionate about improving patients’ lives allowing them to see brilliantly and we would love you to be part of the team making this happen!Additionally, if you see this fits for another person, do share this opportunities with them.