We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

This role can be done anywhere within Europe remotely.

Early Access / Compassionate Access Associate

Implement protocol logistics (PUT-RD), clinical data collection and entry under the responsibility of the project team, and in conjunction with the client, during the performance of authorized Early Access/Compassionate Access.


Your Job

• Ensures the follow-up of Early Access/Compassionate Access related activities:

• Verification of the information reported on the inclusion forms
• Request clarifications or missing data from healthcare professionals in the context of patient inclusion
• Requesting a medical opinion from the Early Access/Compassionate Access’ holder if required by the client and/or in case of questioning
• Approve or deny patient inclusion requests
• Enter data into Early Access/Compassionate Access tracking tables or eCRF
• Filing and recording of inclusion forms

• Verification of information reported on patient follow-up forms
• Request clarifications or missing data from healthcare professionals / Early Access/Compassionate Access’ holder in the context of patient follow-up forms
• Follow-up with healthcare professionals on patient follow-up forms, if necessary
• Enter data into the Early Access/Compassionate Access tracking tables or eCRF
• Filing and recording of patient follow-up forms

• Sends administrative information for Early Access/Compassionate Access drug listing to pharmacies
• Transmission of the request for quotation and listing requests from the pharmacies to the distributor, if necessary
• Verification of the information reported on the purchase orders
• Request clarifications or missing data from pharmacists, if necessary
• Follow-up with pharmacists on purchase orders to be received, if necessary
• Approval of purchase orders
• Enter data into the Early Access/Compassionate Access tracking tables or eCRF
• Transmitting purchase orders to the distribution site, after approval
• Informing pharmacists of delivery times once confirmed by the distribution site
• Filing and recording of purchase orders

• Responding to questions related to patient inclusion and follow-up
• Respond to incoming requests and medical information requests that are answered in the SmPC and/or FAQ
• Forwarding to the appropriate departments:
  • Questions related to medical information requests that are not answered in the SmPC and/or the FAQ
  • requests concerning a Pharmacovigilance declaration
  • requests concerning Quality complaints

• Verification of the information reported from the inclusion forms
• Verification of information reported from the patient follow-up forms
• Request clarifications or missing data from the project team
• Sending the follow-up tables to the clients concerned, according to the predefined schedules

Your Profile

• Scientific profile (minimum 2 years of higher education) or initial training in health (doctor, pharmacist, veterinarian, dental surgeon, nurse, midwife): Senior hospital technician, state-registered nurse, laboratory technician
• Ideally, first significant experience in the medical or clinical research environment
• Fluency in French (imperative) and professional English
• Pack Office

If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

Agencies only by prior agreement for the specific job opportunity.