Drug Safety Project Lead job in

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

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As part of our Safety Reporting Group in ICON’s Global Regulatory Affairs, our Drug Safety Coordinators (DSC’s) contribute to our culture of process improvement, serve as lead Drug Safety Associate (DSA) on global medical or safety projects as assigned, train/mentor newly hired DSA staff as requested, perform expedited and periodic safety reporting, maintain projects and liaise with Sponsors, ICON project managers and investigational sites as required.

Purpose of the Role

As a Drug Safety Coordinator, you will be expected to;

Lead projects and take on project management activities.
Prepare regulatory documentation packets and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, and Principal Investigators and business partners.
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.
Ensure the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors.
Serve as support to Safety Reporting Group management in all aspects of departmental activities , as needed
Serve as technical expert with regard to all aspects of safety reporting

Role Requirements

The successful candidate will have significant relevant clinical research/pharmaceutical industry experience, in pharmacovigilance/drug safety, with thorough knowledge of global safety processes/regulations and medical terminology/coding systems.
Must be fluent in written and verbal English with good communication skills and basic computer skills. Detail orientated and capable of working effectively within a team environment.
Medical/science background (nursing preferred) and/or bachelor’s degree or local equivalent.

Benefits

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

What’s Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

*LI-NM1

A better career. A better world. A better you.

Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader.
See all locations

Read more

List #1

Day in the life

Home Sweet Office: Why Culture Compatibility Matters

Teaser label

Inclusion & Belonging

Content type

Blogs

Publish 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

Teaser label

Explore how aligning with the right company culture can transform your work environment into a home away from home.

Precision Medicine: How Personalised Therapies are Transforming Healthcare

Teaser label

Industry

Content type

Blogs

Publish 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

Discover how precision medicine is revolutionising healthcare by tailoring treatments to each patient.

Day in the life of a Clinical Data Mangement Project Manager

Teaser label

Our People

Content type

Blogs

Publish 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

Teaser label

Deepak shares his experience as Clinical Data Management Project Manager at ICON Strategic Solutions.

View all

Similar jobs at ICON

CRA II

Salary

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

Sarah Wood

Author

Sarah Wood

Read more Shortlist Save this role

Senior CRA

Salary

Location

Chile, Santiago

Department

Clinical Monitoring

Location

Santiago

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

Reference

JR116100

Expiry date

01/01/0001

Author

Sarah Wood

Author

Sarah Wood

Read more Shortlist Save this role

CRA II

Salary

Location

Chile, Santiago

Department

Clinical Monitoring

Location

Santiago

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Monitoring

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

JR113902

Expiry date

01/01/0001

Author

Sarah Wood

Author

Sarah Wood

Read more Shortlist Save this role

Clinical Research Associate I - Histologist

Salary

Location

United States

Department

Clinical Monitoring

Location

United States

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

ICON is looking for a CRA or Histologist for a CRA I position with one of our FSP clients!

Reference

2024-110221

Expiry date

01/01/0001

Author

Jamie Pruitt

Author

Jamie Pruitt

Read more Shortlist Save this role

Study Start Up Associate I

Salary

Location

US, Raleigh (PRA)

Location

Raleigh

Wilmington

Blue Bell

Lenexa

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

Job Type

Permanent

Description

Reference

JR119591

Expiry date

01/01/0001

Author

Tina Geer

Author

Tina Geer

Read more Shortlist Save this role

Clinical Sample Processor I

Salary

Location

US, New York, NY, Farmingdale

Department

Full Service - Development & Commercialisation Solutions

Location

Farmingdale

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Supplies

Job Type

Permanent

Description

Reference

JR118493

Expiry date

01/01/0001

Author

Zach Hines

Author

Zach Hines

Read more Shortlist Save this role

Full Service

ICON Strategic Solutions

Government and public health services

Global Business Services

Overview of Service Lines

Why icon? full service mean for you?

graduate What does full service mean for you?

Drug Safety Project Lead

About the role

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

ICON and you

ICON history

Career Pathways

Benefits & Rewards

DE&I

Environmental, Social & Governance

Women in IT

A better career. A better world. A better you.

Who we are

Government and public health services

Why icon? full service mean for you?

Drug Safety Project Lead

Send me a message

About the role

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

ICON and you

ICON history

Career Pathways

Benefits & Rewards

DE&I

Environmental, Social & Governance

Women in IT

A better career. A better world. A better you.

Who we are