HireDiversity

Manila, PH

Device Malfunction Physician-000009A8

Description

The Johnson & Johnson Family of Companies is comprised of more than 250 operating companies in 60 countries employing approximately 129,000 people. Our companies develop and market products in three business segments: Consumer, Medical Devices & Diagnostics and Pharmaceuticals. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Device Malfunction Physician

(Based in Parañaque City, Metro Manila, Philippines)

The primary role of the Device Malfunction Physician Lead is to ensure compliance to the processing and monitoring of adverse event reports for post-marketed products following company Standard Operating Procedures, with worldwide dafety regulations, corporate and regulatory guidance documents and corporate policies. As required, the Device Malfunction Physician will provide key leadership in medical review group and its processes.

Principal responsibilities:

- Execute product safety management processes- perform case review, safety and medical assessment, case validation (medical coding, causality assessment, seriousness assessment, safety narrative writing).
- Oversee and monitor the safety profile of products within the assigned product portfolio.
- Perform medical review of adverse events and malfunctions in the global safety database and medical review of line listings for these cases.
- Perform seriousness assessment of cases, when medical judgement is required.
- Provide training and guidance to product safety associates on medical aspects of case processing.
- Assume responsibility for quality of data processed and reviewed.
- Ensure compliance of operations with governing regulatory requirements.
- Implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.

Qualifications


- Doctor of Medicine or Doctor of Dental Medicine
- Board Certified Clinician, specialization is a plus
- Must have 1-2 years relevant product safety experience in the healthcare industry
- Must have the ability to analyze and interpret data from safety databases and medical literature and present complex data in a concise and understandable scientific manner, both verbally and in written format
- Good command of English, both verbal and written
- Good interpersonal skills, strong communication and influencing skills
- Awareness of and adherence to Johnson & Johnson Credo values

Primary Location:Asia Pacific-Philippines-National Capital-Manila
Organization: Johnson & Johnson International (Singapore) Pte Ltd (8438)
Job Function: Drug & Product Safety Science