Safety Writer

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.
 

We are looking for a Safety Writer to join our expanding Pharmacovigilance & Patient Safety team to plan and coordinate the entire process of Aggregate Safety Reporting and to assume responsibility for quality control.

In this challenging position your key responsibilities will include: 

• Acting as safety writer as assigned

• Assisting project teams on safety surveillance for medicinal products and devices, risk management and medical coding questions

• Contributing to ICON initiatives for the implementation of new or enhanced

  • Pharmacovigilance processes and best practises

  • Pharmacovigilance systems, databases and tools

• Writing all sections of aggregate safety reports regardless of complexity, updates to dRMPs/RMPs or REMS and/or writing Pharmacovigilance Agreements at all complexity levels

• Assisting Safety Scientists with Pharmacovigilance System Master Files (PSMF) maintenance activities

You apply excellence in understanding company policies and procedures, computerized systems and applications, pharmacovigilance, financial project planning and impact, presenting and communicating to stakeholders on different levels.

You work well independently and with a team, support other team members, think analytically and with a resolving attitude. You are an “out of the box” thinker and aim for continuous improvement.

You act under limited supervision without instructions on routine work and with frequent functional management interaction on new work or special assignments. You interact well with representatives from other departments on obtaining or providing necessary information or data.

You are:

Well informed, committed and a thorough worker

Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

• Clinical research or post-marketing safety surveillance experience with a minimum of 3-5 years of experience in pharmacovigilance or medical coding or in a similar field

• Basic knowledge of regulatory environment pharmacovigilance and patient safety activities

• Skills with industry standard safety or clinical databases

• Ability to provide leadership for teams including planning, supervision and implementation of processes on project level

• 2-4 years experience in writing safety documents

• Fluency in English reading, writing, and speaking and in host country language

• Undergraduate degree or its international equivalent in clinical science or health related field, or equivalent work experience

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.