Specialist I Pss

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

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