Pharmacovigilance Assistant I/II

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

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 quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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.