Icon Pharmacovigilance Drug safety Associate jobs
Icon Pharmacovigilance Drug Safety Associate Job Opportunities for all life sciences candidates
ROLE; Drug Safety Associate /Sr. Drug Safety Associate/ Drug Safety Coordinator
About the role of Drug Safety Associate Job;
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing outsourced services to pharmaceutical, biotechnology, medical devices,d government,t, and public health organizations.
With our patients at the centre of everything we do, we help accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and are the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Job Summary of Drug Safety Associate Job:
- Perform processing for all safety events, medical information call handling activities, and other medically-related project information.
- 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 by ICON standards, regulatory requirements, and contractual obligations to Sponsors.
Key Responsibilities of Drug Safety Associate Job:
- As a DSA, you will be expected to perform case processing for serious adverse events, serious and non-serious adverse drug reactions, and other medically-related project information, such as adverse events of special interest and clinical endpoints.
- Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files.
- Serve as a resource for investigational sites and ICON personnel on safety-related issues.
- Assist with the generation of study-specific procedures and with identifying out-of-scope activities in conjunction with the MSS Functional Lead. Review and process safety events (pre-marketing, post-marketing, device, and drug) and other medically related information per assigned tasks and project-specific procedures.
- Review abstracts and full articles to identify safety information from literature sources for pre- and post-marketed products.
- Respond to and process medical information inquiries, including inquiries related to adverse events and product complaints for Clients’ product(s), as per their agreement with ICON.
- Complete adverse event follow-up in writing and by phone based on requirements for each Client
- Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files*
- Perform safety review of clinical and diagnostic data as part of case processing*
- Assist with the generation of project-specific procedures
- Act as lead Drug Safety Associate for local or regional projects
- Support the creation of post-marketing safety activities, such as PSMF, RMP, and PBRER
- Support QPPV as required
- Liaise with the investigational site, reporter, and Sponsor as necessary regarding safety issues.
- Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate*
- Assist with identifying out-of-scope activities in conjunction with the PV Project lead (as applicable)
- Attend project team and Sponsor meetings (including Investigator meetings) and teleconferences as required.
- Perform other activities as identified and requested by management.
You will need the following:
- The successful candidate will have relevant clinical research/pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.
- Must be fluent in written and verbal English with good communication and basic computer skills. Detail-orientated and capable of working effectively within a team environment.
- Medical/science background (nursing preferred) and 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 prioritized building 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 the delivery of performance goals – 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 confidently 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 purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, colour, 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 to perform the essential functions of a position, please let us know through the form below.
