Alcon is seeking a Patient Safety Monitor to join our team in Bangalore. This role focuses on managing case files, ensuring compliance with internal standards and regulatory requirements, and contributing to the safety monitoring of medical devices, particularly intraocular lenses (IOLs). As part of a dynamic team, you will play a critical role in maintaining patient safety by supporting complaint management, regulatory submissions, and safety investigations.
Major Responsibilities
The key results expected in this role include efficient case processing, compliance with regulations, and accurate reporting. Below are the primary duties:
Case Processing:
- Process case files according to Standard Operating Procedures (SOPs).
- Collaborate with affiliate offices to collect necessary datasets and re-assess submitted data.
- Assign event codes and ensure accurate product selection in the database.
- Conduct initial and follow-up assessments using reports, questionnaires, or findings.
- Respond to Manufacturing Quality Assurance (QA) and Health Authority inquiries.
- Initiate quality investigation records when required.
- Schedule expedited and periodic regulatory reports per local and international regulations.
- Ensure compliance with corporate guidelines and programs in all processes.
- Support reconciliation activities and audits when needed.
- Escalate any potential safety concerns to management.
Knowledge Areas:
- In-depth understanding of Alcon products (manuals, promotional materials, product information).
- Familiarity with eye anatomy, common diseases, ophthalmic procedures, and medical terms.
- Proficiency with safety databases and reporting tools.
- Experience with Intraocular Lens (IOL) product complaint management.
Key Performance Indicators (KPIs)
Performance will be evaluated based on:
- Meeting internal and external quality standards.
- Completing case files and reports within deadlines.
- Preparing high-quality regulatory reports for timely submission.
Qualifications and Experience
Education:
- Minimum: Graduation in Science.
- Preferred: Graduation in Optometry, Pharm-D, M. Pharm, BDS, BAMS, BHMS.
Experience:
- Minimum:
- Healthcare professional with 0-2 years of experience.
- Optometry graduate with 0-1 year of experience.
- Preferred: 0-2 years of experience in:
- Device Vigilance / Pharmacovigilance
- Regulatory Submissions / Clinical Research
- Medical Coding / PVPI
Skills and Competencies
- Communication & Listening Skills: Strong verbal and written communication abilities.
- Attention to Detail: Ability to prioritize tasks and manage time effectively.
- Decision-making & Negotiation: Strong decision-making abilities and effective negotiation skills.
- Regulatory Knowledge: Familiarity with medical device safety regulations and post-marketing safety practices.
- Technical Knowledge: Basic understanding of MS Office tools.
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