Senior Drug Safety Associate

ICON is seeking an experienced pharmacovigilance professional with experience reviewing and overseeing the process and management of safety events (clinical (pre-marketing), post-marketing, device and drug) and/or other medically related information per assigned tasks and project specific procedures.
The Senior Drug Safety Associate will perform lead responsibilities in reference to the processing for clinical study safety events, and other medically-related project information. Serve as pharmacovigilance (PV) lead for projects providing project management support, ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information and assist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors.
About the Senior Drug Safety Associate role within ICON:
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.
Generation of project specific procedures/safety management plan/Sae forms templates using the departmental guidance templates.
Act as Pharmacovigilance lead for global and local US projects assigned supporting your line manager and Director.
Liaise with other ICON departments and/or other Sponsor vendors such as data management and clinical project management, medical writing, etc.
Attend study meetings with the clinical team and participate in client meetings related to safety oversight and management, as well as lead PV project team meetings internally and with the client.
Primary client contact in partnering with the sponsor, their sites, etc. as necessary, regarding safety issues in support of the case processing team.
Assist with identifying out of scope activities in conjunction with the PV Project lead (as applicable).
Benefits of working at ICON:
In addition to partnering with the top pharmaceutical and biotech companies in the world we offer a strong benefits package that includes a comprehensive health plan, retirement plans, competitive pay, bonus plans, vacation, and other incentives.
To succeed you will need:
Minimum of 3 years of relevant drug safety and pharmacovigilance experience who possess an RN, Bachelor's in Nursing, or RPH or PharmD, or equivalent experience as a licensed healthcare professional.
Thorough Knowledge of FDA safety guidance's as well as familiarity with EMA industry guidance, working knowledge of safety systems; Argus, ARIS-g, Clinical database knowledge such as RAVE and InForm.
Experience with reconciliation of SAE's against the clinical database
Basic to Intermediate computer skills (Microsoft Word, Excel, Outlook, PowerPoint)
Good communication skills and able to be client facing in meetings, audits and strategy meetings
Self-starter and disciplined
Detail oriented
We invite you to review our opportunities at www.iconplc.com/careers.
What's Next?
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment

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