Drug Safety Project Lead job in

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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

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 Accomodations

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Drug Safety Project Lead

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Government and public health services

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Drug Safety Project Lead

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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

Application process

Who we are