Drug Safety Physician

"At ICON, it's our People that set us Apart"

ICON plc, a leading global Contract Research Organization employing 15,000 people in 40 countries. ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

About the Drug Safety Physician at ICON:

* Perform medical review and oversight of processing for all types of safety events, and other medically-related project information.
* Medical oversight and completion of analysis of similar events, company causality assessment, expectedness assessment, review of MedDRA coding, signal detection, risk management, and pharmacovigilance oversight for assigned projects.
* Assist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, legal and regulatory requirements, and contractual obligations to clients.

Responsibilities Include:

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
* Participate in Business Development activities as requested
* Perform other activities as identified and requested by management

Benefits of working at ICON:

ICON offers an exceptional benefits package that includes a comprehensive health plan, retirement plans, highly competitive pay, corporate bonus plan, time away from work, and other incentives. We provide you with the technology, innovation and resources to be successful in ensuring utmost compliance and operational efficiencies