Drug Safety Associate

Job Description

Job descriptionReview and process safety events (pre-marketing, post-marketing, device and drug) and/or other medically related information per assigned tasks and project specific proceduresPerform review of abstracts and full articles to identify safety information from literature source for both pre and post marketed products.Respond 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/or 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 filesPerform safety review of clinical and diagnostic data as part of case processingAssist with generation of project specific proceduresAct as lead Drug Safety Associate for local or regional projectsSupport creation of post-marketing safety activities, such as PSMF, RMP and PBRERSupport QPPV as requiredLiaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues.Liaise with ICON Medical Monitor, project manager, and other departments, as appropriateAssist 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 requiredPerform other activities as identified and requested by management.You will need: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 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.

Keyskills :
pharmaceutical medicinemedication adherencepharmacy educationmedical affairsclinical trialspharmaceutical carepharmacovigilancedrug interactions