Alcon, a global leader in eye care, is dedicated to helping people see brilliantly. With a legacy spanning over 70 years, Alcon develops innovative products and solutions to treat various eye conditions. We are committed to providing high-quality ophthalmic products and fostering a diverse and inclusive work environment. Join Alcon in our mission to improve lives by enhancing vision.
Responsibilities in the Job
As a Patient Safety Monitor at Alcon, you will play a pivotal role in ensuring the safety and efficacy of our products. Your key responsibilities include:
Case Processing:
- Process case files in accordance with Standard Operating Procedures (SOPs).
- Collaborate with affiliate offices to collect and verify necessary datasets.
- Reassess data, ensure accurate product selection, and assign appropriate event codes in the system.
- Conduct initial and follow-up reporting assessments based on incoming information, including questionnaires, phone calls, and investigation findings.
- Respond to Manufacturing Quality Assurance (QA) requests and Health Authority inquiries.
Regulatory Compliance:
- Launch and manage quality investigation records.
- Schedule expedited and periodic regulatory reports per local and international regulations.
- Maintain adherence to all corporate compliance guidelines and programs.
Expertise Development:
- Develop knowledge of Alcon products, eye anatomy, common diseases, ophthalmic procedures, and eye terminology.
- Utilize safety databases and reporting tools for efficient case management.
Quality Assurance:
- Perform and receive quality feedback on case management and coding.
- Participate in reconciliation activities and audits as required.
- Evaluate and escalate potential safety issues to management.
Qualifications
To excel in this role, you should meet the following qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
- Familiarity with safety databases, regulatory reporting tools, and relevant SOPs.
- Knowledge of ophthalmology, including eye anatomy, diseases, and evaluation procedures.
- Previous experience in case processing or pharmacovigilance is a plus.
Key Skills
- Strong attention to detail and analytical skills.
- Excellent verbal and written communication skills.
- Proficiency in working with databases and reporting tools.
- Ability to manage multiple tasks and meet strict deadlines.
- Strong collaboration and problem-solving abilities.
