Medical Shared Services Technician
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The purpose of the Medical Shared Services Technician is to assist the local legal contact for Pharmacovigilance and the Medical Affairs Director Eli Lilly Benelux to ensure legal duties are executed within the required timelines. You will collaborate with the Medical Affairs team and support them with project management, database management, implementation and follow up of selected medically owned projects.
In addition, the Medical Shared Services Technician serves as Drug Complaint technician, compiles complaints from Belgium and Luxembourg, coordinates follow-up and entry into Complaints database and reports issues and concerns to the Complaint Coordinator.
Core Job Responsibilities
AE receipt and data collection (Belgium/Luxembourg)
·Ensure identification, retrieval, acknowledgment and distribution of Adverse Events (AE) information.
·Collect and document all AEs with products reported spontaneously for marketed products and those serious AEs associated with clinical trials and post-marketing surveillance studies.
·Responsible for appropriate receipt and managing of AE reports received via Customer Connect, e-mail, fax, letter, phone, in person or through the online AE form.
·Report new or follow-up information as it is received.
·Ensure completion of action items.
·Communicate effectively with AE reporters.
Submission DSURs and other safety reports to Agency (Belgium)
·Responsible for mailing Development Safety Update Reports (DSUR) and other Safety reports to the Agency, following regional guidance.
Submission DSURs and other safety reports to Ethical Review Boards/ERBs (Belgium)
·Responsible for submitting DSURs to ERBs.
·Responsible for submitting other safety reports to the applicable ERB.
Safety Mailings to ERBs (Belgium)
·Responsible for generating the necessary expedited case reports (SUSARs) to ERBs that are required to meet local regulatory requirements.
Risk management plans and risk minimization activities
·Help the local contact point with the submission of RMiP plans/activities.
·Ensure entry and follow-up of RMiP metrics.
2. PRODUCT COMPLAINT TECHNICIAN
3. MEDICAL AFFAIRS SUPPORT
Minimum Qualification Requirements
Education & Experience
What we offer
A pharma competitive salary & benefit package