Drug Safety Associate
- Chennai, Trivandrum
- Drug Safety
- ICON Full Service & Corporate Support
- Hybrid: Office/Remote
About the role
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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.
Responsibilties include:
- Entry and submission of safety reports (expedited and periodic) in the Safety Reporting System accordingly to the requirements and timelines.
- Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information.
- Assist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors.
- Perform case assignment on regular basics for all the incoming cases.
- Involvement in SRG project set up and maintenance activities
The role:
• As a DSA, you will be expected to perform safety reporting activities for SUSAR and periodic reports to Competent Authorities, Ethics Committees and Investigators
• Provide oversight of the timely submissions as per reporting requirements
• Serve as a support to the safety reporting group members
• Assist with generation of study specific procedures and with identifying out of scope activities in conjunction with the MSS Functional Lead.
You will need:
• The successful candidate will have relevant clinical research/pharmaceutical industry experience, preferably in safety reporting/pharmacovigilance in clinical trial studies
• 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 background /HCP or life science 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.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
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 Learn more about Our Culture at ICON
Day in the life
Teaser label
Inside ICONContent type
BlogsPublish date
09/29/2022
Summary
A Drug Safety Associate is responsible for assessing the safety of pharmaceuticals drugs once they’re on the market. Using standardised guidelines, they determine whether the medication causes any adv
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