Medical Safety Clinician - Interventional Cardiology

Antler; Taguig; On-site; PHP 600,000 - 900,000; Full time

Job summary

Johnson & Johnson is seeking a Medical Safety Clinician to assist and support safety evaluations for assigned products, coordinating Post Market Surveillance plans and reports, and preparing Health Hazard Evaluations.

The role includes reviewing data from Clinical Evaluation Reports and literature, coordinating data collection with vendors, and supporting regulatory reporting and scientific presentations in a global, matrix environment.

Qualifications

• Advanced academic degree in a health-care discipline (e.g. MD, DO, ARNP etc.).
• Previous experience within the medical device or pharmaceutical industry and at least 6-year of post-marketing safety data analysis preferred but not required.
• Familiarity with industry principles of device safety, device development, pharmacology, biostatistics, and epidemiology.
• Basic knowledge of common data processing software.

Responsibilities

• Review and classify the data collected as part of Clinical Evaluation Reports, literature reviews and other surveillance activities.
• Manage outsourced data collection, organization preparation with vendors as required.
• Support Physicians, such as case series review, data review, draft reports.
• Assist in organizing or running searches of safety or regulatory databases.
• Provide support to related PMS activities such as Periodic Safety Update Reports (PSUR) preparation of reports for surveillance supports and collating reports for review of product quality data, support of health hazard evaluations, scientific presentations etc.
• Participate in preparation, analysis and writing of ad-hoc and aggregate regulatory reports and, labeling support documents.

Skills

Post-marketing safety analysis

Device safety knowledge

Biostatistics

Epidemiology basics

Data processing software

Education

Advanced academic degree in healthcare

Tools

Excel

PowerPoint

Microsoft Word

Job description

Johnson & Johnson is seeking a Medical Safety Clinician to assist and support safety evaluations for assigned products, coordinating Post Market Surveillance plans and reports, and preparing Health Hazard Evaluations.

The role includes reviewing data from Clinical Evaluation Reports and literature, coordinating data collection with vendors, and supporting regulatory reporting and scientific presentations in a global, matrix environment.