PVG Associate (Fixed Term Temp)

Bionical Emas is the only CRO to combine Clinical Development, Early Access Programs and Clinical Trial Supply, delivering a unique, seamless approach to bring life-changing medicines to patients around the world.

With clients, staff and offices around the globe, we offer a varied and international experience. Our clients range from smaller biotech’s to large global pharmaceutical companies, all with different needs and expectations.  As a business, we have invested heavily in ensuring we have the systems, processes, and people, to deliver for the very varied requirements of our clients. The culture of Bionical Emas is friendly, flexible and supportive, where all staff are encouraged to grow, develop and exceed their expectations.

Main Responsibilities 

• Case processing (data entry including MedDRA coding and submission  for medical review)

• Case receipt 

• Case tracking – including establish and maintain tracking systems

• Submission of case reports to EudraVigilance, CA’s, ethics and investigators  as required

• Submission of aggregate reports including tracking

• Operate PV data systems such as PV Works

• Ensure compliance with regulatory requirements including contribution to  client and/or Bionical Emas quality systems

• Follow up – identification of follow up data required, schedule for follow up  and sending initial and repeat reminders.

• Reconciliation (with clinical data management, medical information data etc.)

Key things we are looking for

• Bachelor’s / Life Science degree is preferable

• Experience within a CRO environment would be advantageous

• Experience working with small biotech companies would be advantageous

 

 

Make a difference 

At Bionical Emas, we are committed to supporting our clients and our staff, so that they can bring life-changing medicines to patients around the world. Join Bionical Emas on our mission to make a difference.