Main activities
- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial.
This includes, but is not limited to: o entry of safety data onto adverse event database(s) and tracking systems
- ** review of adverse events for completeness, accuracy and appropriateness**:
- ** write patient narratives**:
- ** code adverse events accurately using MedDRA**:
- ** determine expectedness/listedness against appropriate label**:
- ** identifies clinically significant information missing from initial reports and ensures its collection**:
- ** ensure case receives appropriate medical review**:
- ** prepare follow-up correspondence consulting the medical staff accordingly.
**:
- Work with Data Management or client on reconciliation of safety databases.
- Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
- Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting.
- Maintains a comprehensive understanding of Covance Safety's Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
**Experience**:
- High degree of accuracy with attention to detail.
- Functions as a team player.
- Good Communication.
- Knowledge of medical and drug terminology desirable.
- Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation.
- Familiarity with ICH Guidelines
- Good written and verbal communication skills.
- Ability to work independently with moderate supervision.
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial
Education/Qualifications/Certifications and Licenses
- Associates Degree in Health Care Area+ 3-4 yrs relevant experience (or 1-2 yrs safety experience)
- Fluent English level
**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.
We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.
We encourage all to apply.
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