Patient Safety Associate Scandinavia

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.

Patient Safety Associate Scandinavia

Fixed term until end of 2025

Reporting to Sr. Patient Safety Manager, Nordics

About Lilly:

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

The Opportunity:

We have an exciting opportunity to join our Nordic Patient Safety team for a fixed-term contract as Patient Safety Associate Scandinavia. The position is based in Denmark and includes responsibility for a broad range of Pharmacovigilance activities for Denmark, Iceland, Norway, Sweden and Finland.

You will be part of an engaged and diverse Nordic Team with colleagues across the Nordic countries. The team focus is on inclusion, innovation and delivering results. You will work in an exciting international and cross-functional environment, closely collaborating with your immediate team and other colleagues to ensure safety of our products to patients.

This is your opportunity to make a difference in an innovative global company in a position characterized by strong teamwork, impact, and high integrity.

Key Responsibilities:

In close collaboration with your colleagues in the Nordic Patient Safety team and Global Patient Safety, you will be involved in various affiliate-related pharmacovigilance tasks, including:

• Adverse event (AE) management: Point of contact for collection of AE reports, timely case entry into the safety database, case follow-up activities, reconciliation of case reports with various stakeholders, quality check and archiving of pharmacovigilance documents.
• Submission of pharmacovigilance documents to the national authority and Ethics Review Boards as required e.g. expedited and periodic safety reports.
• Literature screening of local medical journals.
• Monitor national pharmacovigilance legislation
• Ensure appropriate interpretation and implementation of national pharmacovigilance legislation/regulation for both drugs and devices.
• Ensure appropriate communications between affiliate patient safety, Global Patient Safety, and other relevant stakeholders, including product complaints, medical, marketing, and regulatory affairs).
• Ensure that local Third Parties’ Pharmacovigilance agreements are in place, up to date and followed as required.
• Provide AE training for affiliate employees and/or Business partners and support affiliate personnel in patient safety requirements and processes.
• Support in maintaining the Pharmacovigilance System Master File (PSMF) and associated local documents.
• Maintain, review, and update local Standard Operating Procedures (SOPs).
• Perform activities related to Risk Minimization Plans.
• Strive for inspection and audit readiness and participate in aligned affiliate inspections, audits, and assessments.
• Attend appropriate external symposia, conferences, and trade organization networks to develop and sustain an appropriate level of professional expertise.

You will come to us with:

• Relevant scientific degree or bachelor’s degree in the pharmaceutical, physical, or health care related field.
• Fluent (written and spoken) in Danish, Norwegian or Swedish, and ability to read and understand the other Scandinavian languages (Danish, Norwegian, Swedish), including professional knowledge of medical terminology.
• Professional knowledge of English, including medical terminology.
• Effective communication skills to interact with various groups and individuals.
• Well organized, structured and with attention to detail.
• Strong IT skills (Microsoft Word, Excel, Adobe).

Additional preferences: