Pharmacovigilance Assistant II

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From 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 success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Role Summary:

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As part of our Pharmacovigilance and Safety Services team you will contribute to our culture of process improvement, providing administrative support on global projects.

Job Responsibilities:

• Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes.

• Provide support to project teams as required.

• Distribute safety reports to Sponsors, sites, and applicable ICON personnel in accordance with  Standard Operating Procedures and Project Specific Procedures.

• Coordinate setup of required systems and mailboxes during study startup (mailboxes, distribution lists, shared drives, tracking tools, etc.).

• File all documents within allotted timeframes, including maintenance of project mailboxes and maintenance of TMF and E-TMF, including performing quality control checks.

• Maintain data entry for safety event and miscellaneous tracking logs for all current projects.

• Assist with organization and planning of meetings (room planning, set-up, and attendee logistics), including preparation and distribution of presentations, agendas, and meeting minutes, as requested.

• Distribute all subject specific material to appropriate ICON staff.

• Daily entry into, and maintenance of, appropriate tracking systems (e.g. SAE/safety event tracking systems).

• Maintain project training records for all assigned project team members.

• Handle mailing activities (Couriers, Post Room etc.).

• Maintain departmental and global calendars as required.

• Perform archiving activities as required.

• Updating and maintenance of project database information systems.

• Perform regular testing of fax numbers and e-mail addresses as required.

• Maintenance, coordination and updates of BOX Rooms.

• Coordination of translation of documents for projects.

• Completion of monthly metrics.

• Handling requests for literature and articles.

• Assistance with audit schedules and arrangement, including preparation of documents.

• Maintain office supplies and equipment.

• Assist with generation/distribution of project specific procedures.

• Support QPPV, including PSMF activities as required.

• Attend project team and Sponsor meetings and teleconferences as required.

• Perform other activities as identified and requested by management.

Job Requirements:

• Excellent computer skills (Microsoft Word, Excel, Outlook, PowerPoint).

• Familiarity with standard office equipment.

• Excellent verbal and written communication skills.

• Detail-oriented.

• Experience in Pharmaceutical/CRO environment (advantageous).

• Fluent in written and verbal English and the local language.

• Excellent organizational and time management skills.

• Knowledge of medical terminology (advantageous).

• Ability to work effectively independently and within a team environment and across global teams.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’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 programs. In 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 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.

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