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Medical Reviewer Rdv Safety Reporting

2+ years
Not Disclosed
10 Dec. 25, 2024
Job Description
Job Type: Full Time Education: MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Medical Reviewer RDV Safety Reporting

Location: Bangalore, India
Company: Alcon
Employment Type: Full-Time
Shift Timing: 1:00 PM to 10:00 PM IST
Posted On: 15 Days Ago
Time Left to Apply: 2 Days (End Date: December 28, 2024)


Job Summary:

Alcon is hiring a Medical Reviewer RDV Safety Reporting to join their team in Bangalore, India. This role involves serving as the local subject matter expert for Medical Risk Assessment activities related to safety and regulatory documentation of marketed products. The Medical Reviewer will collaborate with internal stakeholders, ensure the quality of safety deliverables, and drive continuous improvement initiatives to optimize post-marketing surveillance processes.


Key Responsibilities:

  1. Medical Risk Assessment & Documentation:

    • Author safety-related regulatory documentation for marketed products across multiple technology platforms in assigned countries.

    • Draft high-quality risk assessments for health authority report submissions, meeting deadlines.

  2. Operational Monitoring & Reporting:

    • Monitor risk assessment activities and escalate concerns to the Global Device Vigilance management team.

    • Evaluate and recommend solutions for any identified risk assessment issues.

  3. Quality Assurance:

    • Ensure all safety deliverables meet internal and external quality standards, adhering to timelines.

    • Support continuous improvement initiatives for risk assessment processes.

  4. Training & Development:

    • Support product and clinical education training needs within the department, including the development of training materials for associates.

  5. Stakeholder Management:

    • Establish and maintain relationships with stakeholders to fulfill post-market regulatory requirements for risk assessment activities.

    • Address audit/inspection questions related to risk assessment processes.


Qualifications:

  • Education: MD (Medical Doctor).

  • Experience: Experience in medical risk assessment and safety reporting is desirable.

  • Skills: Strong understanding of regulatory requirements and safety documentation, excellent communication skills, and the ability to collaborate with cross-functional teams.


About Alcon:

Alcon is a global leader in eye care, committed to providing the highest quality products and services for vision care. Alcon is an Equal Opportunity Employer and values diversity in its workplace, ensuring a discrimination-free environment for all employees.


Application Instructions:

  • Time Left to Apply: Apply by December 28, 2024.

  • Important: Alcon does not offer positions without interviews and will never ask for money from job seekers.

For further details or to apply, visit Alcon's official careers page.


Interested? Apply now to join Alcon in making a difference in the world of eye care and safety reporting!