The role provides medical expertise to evaluate safety data and determine the relevance of serious adverse event reports within the product's safety profile
Job Summary
The role provides medical expertise to evaluate safety data and determine the relevance of serious adverse event reports within the product's safety profile.
This position serves as a senior technical leader responsible for preparing aggregate reports and participating in matrix management activities alongside Post-Marketing Safety Experts.
Candidates must possess a valid medical degree, three years of clinical practice experience, and in-depth knowledge of global regulatory requirements like GCP and ICH guidelines.
Matching Summary
The role provides medical expertise to evaluate safety data and determine the relevance of serious adverse event reports within the product's safety profile.
Skills & Requirements
Must-have
Medical degree from accredited school
3 years clinical medicine experience
Knowledge of GCP and ICH guidelines
Pharmacovigilance case processing expertise
Aggregate report preparation skills
Nice-to-have
2 years pharma industry experience
Valid medical license in work region
Experience with safety databases
Strong verbal and written communication
Matrix management and team leadership
Key Requirements
Medical degree from accredited international school
Three years practicing clinical medicine after degree
In-depth knowledge of GCP and ICH guidelines
Sound knowledge of Pharmacovigilance ICSR and Aggregate reports
Valid medical license or equivalent from region of work