SR Medical Reviewer II

How will you make an impact?

The Sr. Medical Reviewer II is responsible for reviewing and evaluating adverse event (AE) reports, ensuring accurate pharmacovigilance medical assessments, compliance with regulatory requirements, reviewing and documenting global literature safety findings and the overall quality of safety data. The role requires close collaboration with cross functional teams including pharmacovigilance team and healthcare professionals to ensure patient safety and product efficacy in ophthalmic products.

What will you do?

Post Market Product Surveillance

• Assist with assessments and evaluations of global product complaints and adverse events including risk assessments (health hazards assessments/evaluations),
• Execute global literature searches, documentation and case processing of applicable publications across all product lines.
• Conduct monthly and annual literature reviews of safety information.
• Maintain detailed documentation of all clinical assessments and supporting clinical rationales.

Pharmacovigilance/Medical Safety

• Perform in-depth medical assessments such as Individual Case Safety Reports (ICSRs), and Medical Device Reports (MDRs)
• Review and verify the accuracy of initial AE case processing, including case seriousness and expectedness, medical coding (MedDRA), narrative writing, and consistency in data entry.
• Review and verify the accuracy of final AE case processing, including case seriousness and expectedness, medical coding (MedDRA), narrative writing, and consistency in data entry.
• Provide ongoing support and guidance on clinical follow-up activities related to product complaint and adverse event reports

Safety/Risk

• Contribute clinical knowledge for implementing and upholding risk management strategies.
• Adhere to documentation and approvals of assessments/evaluations of customer complaints as required by each region's regulatory requirements.
• Support clinical rationales; ensuring all complaint documentation meets Good Documentation Practices.
• Provide medical and clinical expertise regarding potential product quality and/or safety issues including assessment of non-clinical findings and medical impact to patients.

Cross-functional Collaboration

• Work closely with internal cross functional teams such as, Medical Affairs, R&D, Quality, Regulatory, Commercial/Marketing to ensure high-quality pharmacovigilance and Medical Safety deliverables.
• Communicate with external vendors, customers, patients, scientific community as needed for collection of data and required follow-up

Audits & Inspections

• Participate in internal audits and regulatory inspections by ensuring accurate documentation and compliance with pharmacovigilance processes.

Continuous Improvement

• Stay updated on pharmacovigilance and medical guidelines, participating in relevant training programs to maintain best practices.

How will you get here?

• 8 years industry experience or relevant clinical experience (including advanced degrees)
• Strong understanding of pharmacovigilance regulations and guidelines.
• Knowledge of ophthalmology a plus
• Proficiency with complaints and pharmacovigilance databases (CATSWeb, Veeva Safety etc.)Excellent attention to detail and medical writing skills.
• Strong computer skills with experience using Excel, Word, Outlook, ERP System and Customer Contact database.
• Excellent communication and team collaboration abilities
• Bachelor's degree or higher in a biologic science with preference towards healthcare or medical profession (e.g., nurse, nurse practitioner, or other related medical/scientific field).This position requires an active, unencumbered license as a Registered Nurse or Nurse Practitioner

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.
Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve the eyesight of people worldwide. And because we're a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last three years!
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.