Medical Safety Analyst
Shanghai, CHINA
Job description
JOB DESCRIPTION:
Core Job Responsibilities:
- Independently collects and assesses adverse event information in a compliant and timely manner in order to meet epplicable regulatory requirements in China (100+ adverse event reports/week).
- Develops, monitors, and communicates product safety profiles for new and existing AN products sold in China. Develops local processes & medical safety SOPs to ensure consistency and regulatory compliance in the conduct of post marketng safety & survedlance activities in China.
- First line response to high nipact/ serious medical complaints from consumersl HCPs; Provides medical assessment and timely follow up to address customer/HCP concerns (including aite visits If necessary).
- Prepares safety related memos/reports In response to ad hoc requests received from internal and external parties to support the China business.
- In collaboration with Quality Assurance, evaluates on an ongoing basis product safety data to proactively identify and address quality issues that could have medical safety mipact
- Completes medical safety assessments for non-conforming/potentially non-conforming batches of Abbott Nutrition product prior to release to the mar1*etplace.
- Provides support fOr clinical study teanis and effectively addresses safety related aspects and issues for clinical studies in China.
JOB FAMILY:
Medical & Scientific Affairs
DIVISION:
ANRD Nutrition Research & Development
LOCATION:
China > Shanghai : 388 Nan Jing Road West
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable