Assists in managing the receipt, processing, and maintenance of safety related information for Abbott Nutrition products in compliance with applicable regulatory requirements
Job Summary
Assists in managing the receipt, processing, and maintenance of safety related information for Abbott Nutrition products in compliance with applicable regulatory requirements.
Responsible for timely and compliant receipt, processing, exchange, and submission of Individual Case Safety Reports (ICSRs) for clinical trial and post-marketing data.
Supports the maintenance and oversight of the pharmacovigilance system for Abbott Nutrition products registered as drugs in China, ensuring alignment with global SOPs and local regulations.
Matching Summary
Assists in managing the receipt, processing, and maintenance of safety related information for Abbott Nutrition products in compliance with applicable regulatory requirements.
Skills & Requirements
Must-have
Adverse Event Management
Pharmacovigilance System Maintenance
Regulatory Compliance
Aggregate Safety Reporting
Vendor Management
Safety Training Coordination
Nice-to-have
Strong commitment to scientific quality
Interpersonal communication skills
Ability to prioritize workload independently
Key Requirements
8-10 years pharmacovigilance relevant experience
Bachelor's degree in life sciences, medical, or pharmacy
Understanding of domestic, regional, and global regulations