Provide Pharmacovigilance (PV) support for patient safety risk management in clinical studies and life cycle management of responsible company product(s)
Partner with cross functional teams for safety reporting
Maintain current knowledge and understanding of regulations, ICH guidelines and industry practices in relation to pharmacovigilance (PV)
Keep abreast of new or changes in local regulations, process and industry practices
Minimum Requirements:
Bachelor degree or above of Medical Science or related field.
Desirable: medical/pharmacological background.
At least 2 years working experience as PV physician or 2 years working experience as senior PV specialist in pharmaceutical company; clinical working experience is preferred
Deep understanding of regulations, knowledge and practices required for pharmacovigilance, e.g. ICH guidelines, international pharmacovigilance regulation, Chinese regulations, industry practice, etc.
Main Responsibilities:
Accelerate the improvement of study quality by implementing Quality Assurance (QA) activities and driving quality initiatives, manage the quality risk of clinical studies in compliance with ICH-GCP, Chinese GCP, other related Chinese regulations, study related Standard Operation Procedures (SOP) of the company and study protocol
Support QA head to set up and maintain clinical quality management system, including study related SOPs at company level and electronic systems according to regulations
Carry out study audit, and support study teams and clinical QC personnel on inspection
Maintains current knowledge and understanding of regulations and industry practices in relation to clinical studies
Close collaboration with cross-functional stakeholders to track new or changes in local regulations or process
Minimum Requirements:
Bachelor degree or above in medical science or related field;
Desirable: medical/pharmacological background
At least 2 years proven project management experience in clinical study
At least 2 years as Clinical Process Manager or equivalent
2 years proven training or coaching experience
Good understanding of knowledge and skills required for the successful delivery of a clinical study, e.g. ICH-GCP, Chinese GCP, other study related regulations, study management, site management, monitoring
Understands the regulatory environments and the drug development process.