Safety Writer
Accellacare
Manila
2d ago

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

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