Drug Safety Coordinator

3 days ago

Chennai, India ICON Full time

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’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

The role:
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 team you will contribute to our culture of process improvement, serve as lead Drug Safety Associate on global projects, and train/mentor newly, hired DSA’s and liaise with Sponsors, ICON project managers and investigational sites as required.
- As a DSC, you will oversee and contribute to the preparation of regulatory documentation packets and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, 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

You will need:

- 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 of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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