Senior Associate

• Develop and execute targeted literature search strategies based on clinical protocols,

product names, and other relevant criteria to support a range of functions, including

• Clinical Evaluation Reports (CERs), State of the Art (SotA) reviews, and Safety

and Performance assessments.

• Conduct annual queries for both clinical and nonclinical reports in collaboration

with Regulatory Affairs.

• Provide literature support for Medical Safety and Complaint Intake, as well as

ad-hoc search requests from departments such as Medical Information and

Health Economics and Outcomes Research (HEOR).

• Perform summarization analysis of to identify any new complaints / risks identified in

publications and add to appropriate system(s)

• Execute process activities in accordance with established Standard Operating

Procedures (SOPs).

• Maintain a strong understanding of data requirements for technical and adverse event

(AE) complaints to ensure compliance.

• Collaborate effectively across global time zones to support international operations.

• Review data entry and follow-up documentation for accuracy, completeness, and

timeliness.

• Stay current with company policies, departmental procedures, and relevant work

instructions.

• Demonstrate working knowledge of ophthalmic terminology, including eye anatomy,

common diseases, and procedures.

• Proactively identify and escalate potential safety issues, emerging trends, or areas of

concern to management.

• Ensure adherence to all corporate compliance guidelines and programs.

• Provide support for reconciliation activities and audits as needed.

Role Dimensions:

Number of associates: None

Financial responsibility: None

Impact on the organization: Low

Key Performance Indicators (Indicate how performance will be measured: indicators, activities)

KPIs will be outlined in detail in the goal sheet, and will largely be around below parameters:

• Meets internal and external standards for inclusive search criteria and response time

• Review and close files within prescribed timelines / benchmarks

Ideal Background (State the minimum and desirable education and experience level)

Education Minimum: Bachelors degree Desirable: Bachelor’s degree in

science or healthcare field

Experience

requirement:

Minimum: 1- 3 years relevant work

experience [i.e. device / drug

safety, compliance, quality

assurance, or data analytics]

Desirable: Experience in Medical

Device / Pharma Complaint

Handling / Device Vigilance /

Pharmacovigilance