Drug Safety Manager
About the role
This vacancy has now expired. Please see similar roles below...
The purpose of this role is ensuring expedited and periodic safety reporting compliance. The position covers a broad spectrum of safety reporting activities globally and leadership to the safety reporting team in Europe and South America.
- Ensure compliance with regulatory reporting requirements for safety reporting in clinical trials.
- Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information.
- As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Travel (up to approximately 15%) domestic and/or international as applicable
- Ensure all project safety activities are completed in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and Sponsors processes
- Keep management appraised of any potential/actual study or staffing issues and develop solutions for same
- Develop and implement department training
- Assist in training of other departments, as requested
- Maintain quality review metrics and attend project quality meetings, as required
- Assist with maintenance of project budgets and oversight by identifying out of scopeactivities
- Assist upper management with resourcing and business development activities
- meetings, as requested
- Manage small to midsize drug safety projects, including Sponsor liaison, and management of timelines and budgets, as appropriate
- Ensure audit readiness and/or MSS representation at audits
- Develop safety plans, study specific procedures, and workflows for clients, as requested
- Actively identify options for process improvement
- Supervise maintenance of project drug safety files as regionally applicable
- Coordinate any committee activities as applicable under supervision
- Perform other activities as identified and requested by management
- Manage REG GRA projects in accordance with established timelines , budget, quality standards and/or contractual requirement
- Develop supporting staff skills, encourage growth and provide regular performance feedback
- Provide project and/or line management of assigned REG staff
- Serve as a mentor and role model for REG staff.
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
Teaser label
IndustryContent type
BlogsPublish date
04/12/2024
Summary
Introduction to the Clinical Research Supply Chain The clinical research supply chain plays a crucial role in the successful execution of clinical trials. It encompasses a complex network of activ
Teaser label
Our PeopleContent type
BlogsPublish date
04/08/2024
Summary
At ICON, a global leader in drug and device development services, Catherine Blake has found an environment that fosters career growth and inspires her to excel. As a Director of Clinical Data Sc
Teaser label
Our PeopleContent type
BlogsPublish date
03/27/2024
Summary
Exploring Lucy's Path: From Science to Communications Lucy's career journey is a testament to the power of adaptability and seizing opportunities as they arise. "I've been in Clinical Research si
Who we are
Similar jobs at ICON
Salary
Location
Argentina
Department
Clinical Trial Management
Location
Argentina
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Clinical Project Manager you will have the opportunity to work with one of the world’ s leading pharma & biotech companies, helping them advance new drugs and devices.
Reference
2024-109622
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
United States
Department
Biometrics Roles
Location
United States
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
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
2024-108774
Expiry date
01/01/0001
Author
Jeffrey VillasenorAuthor
Jeffrey VillasenorSalary
Location
Argentina
Department
Clinical Trial Management
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Site Engagement Liaison you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions.
Reference
2024-109844
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
US, Raleigh, NC, 27609
Location
Raleigh
Reading
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Patient Recruitment
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
JR117087
Expiry date
01/01/0001
Author
Mitzi OvertonAuthor
Mitzi OvertonSalary
Location
Brazil, Sao Paulo
Department
Clinical Monitoring
Location
Sao Paulo
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
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
JR117866
Expiry date
01/01/0001
Author
Ana LuciaAuthor
Ana LuciaSalary
Location
Brazil, Sao Paulo
Location
Sao Paulo
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Physician
Job Type
Permanent
Description
Clinical Research Physician - Sao Paulo - Homebased roleICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research
Reference
JR117027
Expiry date
01/01/0001
Author
Elizabeth DaviesAuthor
Elizabeth Davies