Safety Administrative Coordinator

hace 3 semanas

Xico, México Icon A tiempo completo
Job Title: Safety Administrative Assistant

ICON plc is a world-leading healthcare intelligence and clinical research organization. Our mission is to accelerate the development of drugs and devices that save lives and improve quality of life.

This is an exciting opportunity for a Safety Administrative Assistant 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.

Job Function/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.
  • 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.
  • 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.

Experience, Skills, Knowledge Requirement:
  • Experience in Pharmaceutical/CRO environment (advantageous).
  • Excellent computer skills (Microsoft Word, Excel, Outlook, PowerPoint).
  • Familiarity with standard office equipment.
  • Excellent verbal and written communication skills.
  • Detail-oriented.
  • Fluent in written and verbal English.
  • 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.

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