Johnson & Johnson Careers
Clinician, Product Safety and Performance
Requisition ID: 1905770076W
The Medical Safety Clinician assists and supports the medical and scientific functions within safety evaluations for assigned products. Such tasks include preparation and coordination of Post Market Surveillance plans and reports as well as reviews of aggregate safety data. The Medical Safety Clinician will also support Risk Management activities by serving as a coordinator for the acquisition and preparation of data for review from multiple sources to prepare Health Hazard Evaluations.
Principal Duties & 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 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.
• Advanced academic degree in a health-care discipline (MD, Opthalmology).
• Previous experience within the medical device or pharmaceutical industry and at least 6-year pf post-marketing safety data analysis preferred but not required.
• Familiarity with industry principles of device safety, device development, pharmacology, biostatistics, and epidemiology.
• Functional knowledge of EXCEL, PowerPoint, Microsoft Word. Team player, ability to work under tight timelines with poise.
• Ability to interpret, analyze and clearly present scientific and technical data in verbal and written format.
Johnson & Johnson (Philippines) Inc. (8385)
Drug & Product Safety Science