- Monitoring and managing project specific email accounts, incoming faxes and telephone calls. Preliminary triaging of ICSRs to determine classification, priorities and time frames for subsequent activities.
- Enter source information for ICSRs to safety databases, tracking systems and/or project specific report forms ensuring accurate data entry
- Performing preliminary coding of ICSRs using MedDRA, WHODrug and database-specific dictionaries.
- Preparing draft narratives for ICSRs.
- Submitting ICSRs to regulatory agencies, clients or client partners in accordance with predetermined documented distribution rules.
- Responding to logistics enquiries from investigators and site staff participating in Mapi studies.
- Preparing ICSR files for the purposes of third party review including adjudication, review by Drug Safety Monitoring Boards, etc.
- Build and maintain positive and productive liaison with internal and external contacts.
- Effectively prioritize and complete multiple projects within established time frames.
- Identify client issues and develop alternative strategies for consultation with other managers.
- Participate in and support project teams and advise other departments on regulatory issues and strategies.
- Participate and assist in preparations for regulatory inspection/internal audits.
- Other duties as assigned.
Qualifications:
- 4 year degree or equivalent experience
- Sound written and verbal communication skills
- Direct experience and working knowledge of adverse event reporting
- Ability to build positive, productive relationships with colleagues and clients
- Strong computer skills and training in current software applications (MS Office, MS Excel)
- Demonstrates organizational, planning and problem solving skills
- Travel less than 10% annually
Knowledge/Skills/Abilities:
- Displays full knowledge of protocol, regulatory requirements, and company SOPs.
- Identifies, documents, and discusses protocol violations, regulatory non-compliance, and issues involving subject safety.
- Distinguishes between good practice and regulatory requirements.
- Applies knowledge into practice on-site.
.png)
Teaser label
IndustryContent type
BlogsPublish date
04/03/2026
Summary
Understanding Central Monitoring vs On Site Monitoring Monitoring is a core component of clinical trial oversight. It ensures that studies are conducted in line with the protocol, that data is re
.png)
Teaser label
Our PeopleContent type
BlogsPublish date
03/26/2026
Summary
Why Francis returned to ICON: building a long-term career in clinical research Francis Kayamba is a Clinical Research Associate based in Johannesburg, South Africa. He first joined ICON in February
.png)
Teaser label
Our PeopleContent type
BlogsPublish date
03/24/2026
Summary
Career paths are rarely straightforward, especially in the fast moving world of clinical research. For many professionals, gaining experience across organisations can provide valuable perspectiv
Salary
Location
Chile, Santiago
Department
Drug Safety & Pharmacovigilence
Location
Santiago
Remote Working
Hybrid
Job Categories
Import & Export
Job Type
Permanent
Description
Import Export Specialist -Hybrid - Santiago Chile ( 3 days office + 2 days home).We are currently seeking an Import Export Specialist to join our diverse and dynamic team. As an Import Export Speciali
Reference
JR143832
Expiry date
01/01/0001
Read more
Shortlist Save this role
Salary
Location
US, Salt Lake City (PRA)
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
Salt Lake City
Remote Working
Office Based
Job Categories
Clinical Trial Support
Job Type
Temporary Employee
Description
We are currently seeking an Echocardiography Technician to join our diverse and dynamic team. As an Echocardiography Technician at ICON, you will play a key role in supporting cardiovascular diagnosti
Reference
JR145760
Expiry date
01/01/0001
Read more
Shortlist Save this role
Salary
Location
US, Raleigh, NC
Department
Drug Safety & Pharmacovigilence
Location
Raleigh
Remote Working
Remote or Office
Job Categories
Medical Director
Job Type
Permanent
Description
We are currently seeking a Medical Director (Neurology) to join our diverse and dynamic team. As a Medical Director at ICON, you will play a pivotal role in driving medical initiatives within project
Reference
JR143278
Expiry date
01/01/0001
Read more
Shortlist Save this role
Salary
Location
Bulgaria, Sofia
Location
Sofia
Warsaw
Remote Working
Remote or Office
Job Categories
Safety Scientist
Job Type
Permanent
Description
We are currently seeking a Principal Safety Scientist to join our diverse and dynamic team. As a Principal Safety Scientist at ICON, you will be responsible for leading safety assessments and pharmaco
Reference
JR148065
Expiry date
01/01/0001
Read more
Shortlist Save this role
Salary
Location
Poland, Warsaw
Location
Warsaw
Remote Working
Remote or Office
Job Categories
Contracts Administration
Job Type
Permanent
Description
We are currently seeking a Senior Site Contracts Negotiator to join our diverse and dynamic team. As a Senior Site Contracts Negotiator at ICON, you will lead the negotiation of clinical trial agreeme
Reference
JR145278
Expiry date
01/01/0001
Read more
Shortlist Save this role
Salary
Location
Czech Republic, Prague
Location
Prague
Bratislava
Remote Working
Remote or Office
Job Categories
Contracts Administration
Job Type
Permanent
Description
Job Advert posting missing
Reference
JR144800
Expiry date
01/01/0001
Read more
Shortlist Save this role