JUMP TO CONTENT
Shortlist
search jobs Search
About the role ICON and you Application Process Day in the life Who we are

Drug Safety Manager

018026_2

About the role

This vacancy has now expired. Please see similar roles below...

Drug Safety Manager – Safety Reporting Group SRG

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.
 
Role Responsibilities
  • 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.
 
Requirements
·      A minimum of 4 years of relevant clinical research I pharmaceuticalindustry experience, preferably with at least 2 years experience in pharmacovigilance I drug safety.
·     Ability to interact effectively and professionally with various levels ofstaff 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 totravel. Therefore, dependent on the employee's location, the employeemay be required to possess a valid Drivers license.
· Medical/science background (nursing preferred) and/or bachelors degree or localequivalent
 
About ICON
We are a company of 13,500 employees in eighty global locations.  We differentiate ourselves by developing innovative solutions to bring life-saving drugs to market faster in a more cost-effective way with better patient outcomes. We are a top five organization with solid earnings and growth potential. Our belief in excellence is our core value in all that we do for our sponsor partners and the patients that we serve.  As a company we strive to exceed our customers’ expectations in drug development solutions
*LI-NM1
List #1

Day in the life

Endometriosis yellow ribbon
Shining a Light on Endometriosis Awareness Month

Teaser label

Inside ICON

Content type

Blogs

Publish date

04/18/2024

Summary

Endometriosis Awareness: A Vital Cause In March, ICON, through its Networking Organization for Women (NOW) employee resource group, joined the global effort to raise awareness about endometriosis

Teaser label

Endometriosis Awareness Month sheds light on this often-misunderstood condition affecting millions worldwide.

Read more
Data visualisation
The Role of Data Management in Clinical Trials

Teaser label

Industry

Content type

Blogs

Publish date

04/18/2024

Summary

Introduction to Data Management in Clinical Trials In the field of clinical research, data management plays a crucial role in ensuring the success and accuracy of clinical trials. Clinical trials

Teaser label

This blog examines the critical role of data management in clinical trials.

Read more
Medicine on a shelf
Navigating the Clinical Research Supply Chain

Teaser label

Industry

Content type

Blogs

Publish 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

Discover the intricate workings of the clinical research supply chain in this comprehensive guide.

Read more
View all

Who we are

Press play to find out more

Similar jobs at ICON

Manager, Drug Safety

Salary

Location

Japan

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Japan

Business Area

ICON Strategic Solutions

Job Categories

Drug Safety

Job Type

Permanent

Description

・成長性の高い両社の統合により、世界で1-2位を争う規模のグローバルCRO（世界で40,500名規模、日本で1,000名規模）に拡大・補完的な統合にもとづく、クライアントポートフォリオの多様化がもたらす本格的なスケールメリットの実現 ・さまざまな疾患領域への深い知識をはじめとする、両社が育んできた強みを活かした幅広い／質の高いソリューションの提供・最先端のテクノロジーに、スケールメリットが加わるこ

Reference

2024-109906

Expiry date

01/01/0001

Daiki Matsumoto

Author

Daiki Matsumoto
Daiki Matsumoto

Author

Daiki Matsumoto
Read more Shortlist Save this role
Read more Shortlist Save this role
Site Support Manager, Patient Recruitment

Salary

Location

UK, Reading

Location

Sofia

Prague

Budapest

Dublin

Warsaw

Lisbon

Bucharest

Johannesburg

Barcelona

Madrid

Edinburgh

Reading

Warwickshire

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

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 It

Reference

JR117762

Expiry date

01/01/0001

Hajni Howard

Author

Hajni Howard
Hajni Howard

Author

Hajni Howard
Read more Shortlist Save this role
Read more Shortlist Save this role
CRA II

Salary

Location

Colombia

Department

Clinical Monitoring

Location

Colombia

Remote Working

Remote

Business Area

ICON Strategic Solutions

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

2024-109736

Expiry date

01/01/0001

Magda Obregon

Author

Magda Obregon
Magda Obregon

Author

Magda Obregon
Read more Shortlist Save this role
Read more Shortlist Save this role
Clinical Research Coordinator Nurse

Salary

Location

US, Winston-Salem, NC 27103

Location

Winston-Salem

Business Area

ICON Full Service & Corporate Support

Job Categories

Nursing

Job Type

Contractor

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

JR118118

Expiry date

01/01/0001

Mitzi Overton

Author

Mitzi Overton
Mitzi Overton

Author

Mitzi Overton
Read more Shortlist Save this role
Read more Shortlist Save this role
Senior Clinical Research Coordinator

Salary

Location

US, Winston-Salem, NC 27103

Location

Winston-Salem

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Research In-Home Services

Clinic

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

JR117595

Expiry date

01/01/0001

Mitzi Overton

Author

Mitzi Overton
Mitzi Overton

Author

Mitzi Overton
Read more Shortlist Save this role
Read more Shortlist Save this role
Medical Communications/Publications Intern

Salary

Location

US, Blue Bell (ICON)

Department

Full Service - Development & Commercialisation Solutions

Location

Blue Bell

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Intern

Job Type

Intern

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 It

Reference

JR116869

Expiry date

01/01/0001

Jasmine Garcia

Author

Jasmine Garcia
Jasmine Garcia

Author

Jasmine Garcia
Read more Shortlist Save this role
Read more Shortlist Save this role

Browse popular job categories below or search all jobs above