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KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTS
A. Knowledge And Skills:
- Ability to communicate and work within a global team
- Ability to understand and process several levels of information for multiple projects
- Knowledge in ICH, GCP
- Good command of the English language
B. Formal Education And Experience Required:
- Physician, Pharmacist, Nurse or paramedical professional with minimally a Bachelor Sciences.
- Previous experience in coding and coding dictionaries, preferably MedDRA, WHODD
- Previous experience in Clinical Research and/or Drug Development
C. Knowledge And Skills Desirable But Not Essential:
- Working knowledge of various coding systems and related third party tools, familiar
with auto-encoding algorithms
- Familiar with database structure, and able to query them through SQL for example
PRINCIPAL DUTIES AND RESPONSIBILITIES
1.Coding referent for study(ies) he/she is allocated to, primary contact for coding concerns.
2.Medical validation of coding with CSD.Ensure coding reconciliation of SAE with GPE.Help in appropriate documentation and investigations of safety cases in collaboration with GPE, identify reporting issues and provide solutions.
3. Provide input and help in CRF design (pre-printed events, medication categories, etc…).Review study documentation (DRSP, DMP, …) for coding related elements.Propose coding related edit checks to SDM.
4. Attendance to study team meetings and explanation or training to study team members
when appropriate.
5. Assist CSD in providing answers to questions (from Health Authorities, etc…) targeting coded
data.
6. Provide help to the dictionary manager for dictionary and synonyms management.