Alcon Laboratories Malaysia Sdn Bhd is looking for new potential candidates to fill in for QA Medical Complaint Handling Specialist position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
- 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.
Maintain an understanding of information/ data required to be collected for technical and AE complaints to assure compliance with regulations and directives.
Manage technical and AE complaint records for assigned area(s) using designated safety system(s).
Review potential complaint data received via safety system(s) and other methods, as required.
Is cognizant of, and works efficiently within applicable time zones.
Performs all necessary reconciliation activities including for all customer oriented programs in accordance with procedures.
Triage/ address calls from all sources for quality technical complaint, AE, requests for refund/ replacement product and credit.
Adheres to required metrics for all complaint handling responsibilities.
Arrange for replacement, product return and shipping of samples to QA sites for analysis.
Closes files according to established guidelines to meet required timelines.
Maintain a working knowledge of :
a. Company policies and procedures, departmental processes, and associated work instructions.
b. Evolving local and international regulations, guidelines and applicable directives.
c. Alcon products for assigned therapeutics area(s) and corresponding documentation (Product Inserts, Direction for Use (DFU), Manuals, Promotional Materials).
d. Eye anatomy, common diseases, ophthalmic procedures, terminology.
e. Complaint management system, safety database and reporting tools.
f. Informs management of potential safety issues, emerging trends and/or concerns.
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.
- University degree in scientific discipline
- Ophthalmology/ Eye care experience desirable
- Experience working within multinational pharma companies or medical device company desirable
- 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 crossfunctionally
- Computer skills
- Proactive, accountability and results-oriented
- Additional educational requirements as may be mandated by national requirements
- Able to speak in English and additional Language (Mandarin) to deal with our client in China
Learn more at www.alcon.com. See Brilliantly.
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