Drug Safety Physician - can be office or home based in either Poland or Romania
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
To perform medical review and oversight of processing for all types of safety events, and other medically-related project information. Provide medical oversight and completion of analysis of similar events, company causality assessment, and expectedness assessment, review of MedDRA coding, signal detection, risk management, and pharmacovigilance oversight for assigned projects.
Job
* Expect post Covid Travel (approximately 15%) domestic and/or international.
* Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and client processes.
* Provide medical review of safety events (pre-marketing, post-marketing, device and drug) and/or other medically related information per assigned tasks and project specific procedures
* Provide input and review relevant safety information for signal detection and risk management activities
* Perform safety review of clinical and diagnostic data as part of case processing and aggregate reporting
* Provide medical review of aggregate reports (e.g. PSUR, PBRER, DSUR, and ASR)
* Serve as the main pharmacovigilance/safety physician point of contact for the customer for the life-cycle of assigned projects.
* Provide assessment of safety issues arising in clinical trials or in the post-marketing setting and escalate those to the project manager within ICON and discuss the agreed approach on resolution with the client
* Provide assistance in the preparation and conduct of code-break activities
* Provide input and consultancy to the client in the course of generation of the Company Core Data Sheet/Core Safety Information and Product Information
* Provide guidance to Pharmacovigilance and Safety Services staff with regards to the regulatory reporting of adverse events
* Assist with generation of project specific procedures (medical review workflow activities)
* Support QPPV and management as required
* Liaise with investigational site, reporter, and/or client 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 client meetings (including Investigator meetings) and teleconferences as required
Ideal candidate Must Have a Medical degree and have previous experience working for a Pharmaceutical, Biotech or other CRO industry. We are seeking candidates with the ability to review and evaluate clinical data and excellent oral and written communication skills.
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.