Drug Safety Manager
About the role
This vacancy has now expired. Please see similar roles below...
- Ensure that projects within Medical and Safety run efficiently, accurately and in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors
- Ensure the daily project operations of assigned safety projects
- Provide project management on Drug Safety projects
- Oversee Drug Safety and Administrative staff, as assigned
- 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 scope activities
- *Assist upper management with resourcing and business development activities
- *Attend bid defence meetings, as requested
- *Manage small to mid-size 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 MSS projects in accordance with established timelines , budget, quality standards and/or contractual requirements
- *Develop supporting staff skills, encourage growth and provide regular performance feedback
- *Provide project and/or line management of assigned Drug Safety and Administrative staff
- *Serve as a mentor and role model for Drug Safety staff.
- A minimum of 4 years of relevant clinical research I pharmaceutical industry experience, preferably with at least 2 years experience in pharmacovigilance I drug safety .
- Advanced proven relevant clinical research I pharmaceutical industry experience, preferably in pharmacovigilance I drug safety.
- Ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors , or Sponsors
- Demonstration of professional demeanour, judgment and discernment in interactions with clients, colleagues, and other staff
- Thorough knowledge of global safety processes and regulations
- Good knowledge of medical terminology and coding systems
- Very good computer skills
- Excellent organizational skills
- Excellent communication skills
- Very good presentation skills
- Very good ability to mentor staff
- Ability to work independently or lead study teams
- Ability to self-start and show initiative
- Detail oriented
- Fluent in written and verbal English
- Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Drivers license.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Read more
Day in the life
Teaser label
Our PeopleContent type
BlogsPublish date
11/13/2024
Summary
How to Become a Clinical Research Associate: A Step-by-Step Guide The clinical research industry is projected to reach $52.0 billion by 2026, growing at an impressive rate of 5.6% annually. This
Teaser label
Career ProgressionContent type
BlogsPublish date
11/12/2024
Summary
Building a Career in Clinical Data Management Clinical data management roles and responsibilities have become increasingly crucial in modern healthcare research and development. The healthcare ind
Teaser label
Career ProgressionContent type
BlogsPublish date
11/05/2024
Summary
Cultivating a Mindset for Career Success Research consistently demonstrates that professional success depends more on mindset than technical skills alone. Studies from leading institutions reveal
Similar jobs at ICON
Salary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
What you will bring:You will play a key role in independently assisting the team to ensure the most effective and efficient study start up, by providing administrative and tracking support.Supporting
Reference
JR125472
Expiry date
01/01/0001
Author
Florencia Borello TaianaAuthor
Florencia Borello TaianaSalary
Location
US, Blue Bell (ICON)
Department
Full Service - Development & Commercialisation Solutions
Location
Raleigh
Blue Bell
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Physician
Job Type
Permanent
Description
We are currently seeking a Senior Medical Director to join our dynamic Medical Imaging team within ICON. As a Senior Medical Director, you will serve as a subject-matter expert in the deployment of im
Reference
JR125837
Expiry date
01/01/0001
Author
Tina GeerAuthor
Tina GeerSalary
Location
United Kingdom, Switzerland, Germany, Belgium, Spain
Department
Project Management Roles
Location
Belgium
Germany
Spain
Switzerland
UK
Business Area
ICON Strategic Solutions
Job Categories
Project Management
Job Type
Permanent
Description
We currently have an exciting opportunity to join ICON on an FSP program to a top global Pharma. The role is a Clinical Program Manager, permanent and home-based. The Clinical Program Manager is a me
Reference
2024-114943
Expiry date
01/01/0001
Author
Tanzina GuerniAuthor
Tanzina GuerniSalary
Location
United States
Department
Clinical Operations Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
As a Senior CRC Nurse you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114554
Expiry date
01/01/0001
Author
Melissa BennerAuthor
Melissa BennerSalary
Location
United States
Department
Clinical Operations Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
As a Senior CRC Nurse you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114553
Expiry date
01/01/0001
Author
Melissa BennerAuthor
Melissa BennerSalary
Location
United States, Canada
Department
Clinical Trial Management
Location
Canada
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Clinical Scientist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-115068
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica Hawkins