(Senior) Medical Shared Services Associate

at  Lilly

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 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.

PURPOSE:

The purpose of the (Senior) Medical Shared Services Associate role in the Netherlands is to ensure affiliate compliance with internal and external requirements concerning Pharmacovigilance and Regulatory Affairs in the Netherlands, to ensure legal duties are executed and timelines are met. This includes compliance to:

• Drug Safety legal obligations and procedures, documentation and deadlines;
• Labelling and information compliance;
• PSP protocol implementation and compliance;
• Affiliate Labelling Responsible Person (ALRP) activities: perform all tasks related to packaging development and assist the (Senior) Regulatory Affairs Associate.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

1.1 RESPONSIBLE FOR OPTIMIZING THE VALUE OF LILLY PRODUCTS THROUGH THE PROMOTION OF PATIENT SAFETY

• Responsible for basic understanding of Adverse Event (AE) management and workflow elements;
• Responsible for appropriate communications between patient safety local and global and with Product Complaint organization, Medical and Regulatory Affairs;
• To have understanding of the roles and responsibilities of the EU Qualified person;
• Responsible for ensuring compliance with local regulatory compliance and GPS policies, procedures and processes.
• Thorough understanding of laws and regulations;
• Contact person for internal and external parties to ensure/improve compliance of (Serious) AE reporting;
• Act as contact point for agencies regarding pharmacovigilance related topics in case national nominated person is absent. Any issues needs to be escalated to the Executive Director-Pharmacovigilance;
• Responsible for maintaining Pharmacovigilance (PV) training materials;
• Responsible for contacting the Medicines Quality Consultant (MQC), when appropriate.

1.6 ADDITIONAL LOCAL AFFILIATE RESPONSIBILITIES

• Reporting totals, trends, metrics, deviations and compliance of affiliate (S)AE reporting to appropriate functions such as medical lead and E&C manager;
• Spokesperson for Safety procedures concerning pharmacovigilance activities during inspections and/or audits of the Medical Department or specific trials/departments;
• Ownership of Required tool Managing AEs in the Netherlands and associated tools;
• Training, supporting and motivating of all new Lilly Netherlands employees with regards to global and local procedures concerning AE reporting;
• Participate to monthly Medinfo hidden AE/PC identification;
• Manage Safety data archive;
• Manage literature screening on AE reporting;
• Updating affiliate metrics for Pharmacovigilance Systems Master File (PSMF), CMTT tool, Zypadhera metrics.