Job Description

We are recruiting for a Drug Safety Associate to join our Spanish team based in Madrid! We can offer flexible working where you are partly office based and partly home based. This is an excellent opportunity for a Graduate within a science-based discipline, to kick-start their career within Safety and Pharmacovigilance.

You will be responsible for:

Expedited reporting activities eg submitting safety reports mainly in the Clinical Trials settings according to applicable regulations, guidelines, Good Clinical Practice, Standard Operating Procedures and project specific requirements.

Reviewing, assessing and submittingthe safety reports to Regulatory Authority, Ethic Commitees and Sites.

Performing quality control of those submissions, tracking, reconciling, providing metrics.

Reviewing/checking the regulatory Intelligence, perform EudraVigilance reporting, liaise with the \"in country representatives\" for local submissions when needed.

Identify and escalate quality issues as applicable. Properly setup studies files and documentation.

Qualifications

Desirable Skills and Qualifications

Educated to a degree level within a science discipline

Proficient user of MS Excel, to an advance level (Pivot Tables, Macros)

Highly Organised and able to follow processes

Knowledge withinsafety reporting and international regulations

Soft skills to perform the required tasks eg ARGUS safety database configuration and usage - EudraVigilance setup and reporting - EV Product registration knowledge would be highly desirable.

If you feel you have suitable experience and are based in Madrid, we encourage you to apply! You will be rewarded with a competitive salary and benefits package, as well as given the opportunity to develop and grow your Safety/PV career.Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.