Icon plc is a world-leading healthcare intelligence and clinical research organisationFrom molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to 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 the driving force behind our successIcon people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
Icon is seeking a pv scientist to join their team and assist with the ongoing workload supporting their global sponsor client with plans to expand their portfolioIcon has 8-9 fte pv scientists on their team supporting their client whom work closely with client’s mdsThe ideal candidate has worked within the following areas: hereditary angioedema, uc & ibs, diabetes, hypertension, internal medicine, adhd, oncology, surgical patches, wound healing, parkinson’s disease, ppi & pain managementActivities include post-marketing signal detection and signal management, input and review of risk management plans, aggregate safety reports, global and local labeling.
Responsibilities:
Signal detection, evaluation, and management:
Perform proactive safety monitoring and signal detection for marketed products including signal identification, evaluation, interpretation of safety signals and prioritizing signals for full evaluation.
Complete initial assessment of safety signals and prepare draft interpretation of reviewed data for assessing safety signals.
Evaluates and prepares documents to answer internal and/or external requests on safety data including the ib, labeling, aggregate reports, and regulatory submissions.
Plan and execute literature surveillance as needed.
Risk management plans:
Review of rmp/rems including armms and provide input as needed
Risk management activities for post-approval of core/designated core and eu rmps
Periodic (aggregate) safety reporting:
Provides input and review for aggregate reports for submission to the health authorities and other stakeholders, as neededSpecifically pbrers, paders, acos, local safety summary reports, etc
Additional responsibilities:
Review of local labeling uspi & smpc
Representative of label changes when global safety officers aren’t available
Responsible for responses to health authorities’ requests and responses to inquiries from internal and external customers.
Qualifications
Basic requirements:
Healthcare background (rn, pharmd, ph.d)
Minimum 3 years relevant pharmaceutical/biotech industry experience as pv scientist including at least 5 years’ experience in pharmacovigilance
Excellent understanding of pv regulatory environment with working knowledge of fda, ema and ich regulations and good pharmacovigilance (gvp)
Working knowledge of argus
Working knowledge of meddra coding
Benefits of working in icon:
Our success depends on the knowledge, capabilities and quality of our peopleThat’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At icon, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programsIn addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Icon, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassmentAll 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.
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