This vacancy has now expired. Please see similar roles below...
- 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
Inclusion & BelongingContent type
BlogsPublish date
04/29/2024
Summary
Cultural Fit in the Workplace Finding the perfect cultural fit is crucial when searching for a new employer. It goes beyond just the job description and salary package. Cultural fit refers to how
.png)
Teaser label
IndustryContent type
BlogsPublish date
04/29/2024
Summary
Precision medicine is a groundbreaking approach that aims to revolutionise healthcare by tailoring medical treatments to individual patients. Unlike traditional medicine, which adopts a one-size-fi
Teaser label
Our PeopleContent type
BlogsPublish date
04/29/2024
Summary
Deepak is a Clinical Data Management Project Manager at ICON Strategic Solutions, the largest global provider of Functional Service Provision (FSP). He works as a dedicated resource within one of o
Who we are
Salary
Location
Ireland, Dublin
Department
Full Service - Corporate Support
Location
Dublin
Remote Working
Office Based
Job Categories
Legal
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR117509
Expiry date
01/01/0001
Read more
Shortlist Save this role
Salary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Hybrid: Office/Remote
Job Categories
Drug Safety
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
JR116196
Expiry date
01/01/0001
Read more
Shortlist Save this role
Salary
Location
Chile
Department
Clinical Monitoring
Location
Chile
Remote Working
Remote
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-107984
Expiry date
01/01/0001
Read more
Shortlist Save this role
Salary
Location
US, Blue Bell (ICON)
Department
Full Service - Corporate Support
Location
Blue Bell
Remote Working
Office Based
Job Categories
Human Resources
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR117974
Expiry date
01/01/0001
Read more
Shortlist Save this role
Salary
Location
Ireland, Dublin
Department
Full Service - Development & Commercialisation Solutions
Location
Farmingdale
Dublin
Reading
Remote Working
Hybrid: Office/Remote
Job Categories
Drug / Device Regulatory Affairs
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR116607
Expiry date
01/01/0001
Read more
Shortlist Save this role