Hybrid Drug Safety & Product Complaint Associate presso 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.

The purpose of the Drug Safety & Product Complaint Associate is to assist the local legal contact for Pharmacovigilance and the Lead Medical Shared Services to ensure legal duties are executed within the required timelines.

In addition, you will serve as a point of contact for Drug Complaints, compile complaints from Belgium and Luxembourg, coordinate follow-up and entry into complaints database and report issues as appropriate at affiliate level.

You will also support regulatory affairs activities including packaging development activities.

Job Responsibilities

1.Drug Safety

Responsible for optimizing the value of Lilly products through the promotion of patient safety, ensure training within the affiliate.

Handle, for Belgium and Luxembourg, Adverse Events Receipt and Data Collection, Case Management Quality Review, and submission of reports to Agency (Belgium/Luxembourg).

Coordinate the local implementation of risk minimization activities when these activities are included in Risk Management Plan.

Ensure Reporting within Belgian affiliate/Hub level.

2.  Product Complaint

Serve as point of contact for receipt and collection of product complaints.

Ensure the follow up of the complaint by identifying, retrieving, acknowledging the complaints information, collect follow-up, enter the complaint in global complaint database, coordinate and prepare the letters to customers. 

Keep local complaint database updated and ensure internal communication to responsible pharmacist/Complaint Coordinator.

3.  Medical Need Program (MNP)

Participate to the redaction of MNP submissions together with Medical Lead and other functions within the affiliate, communicate with the requesting HCP, and liaise with other department to ensure optimal delivery.

Calendar the periodic reports for Unmet Need division of FAMPH.

Ensure yearly evaluation of the ongoing programs.

4.  Labelling activities

Ensure and coordinate development, implementation and maintenance of printed packaging components for Lilly marketed products according to the legal requirements.

Create full and abbreviated (when applicable) versions of the approved labels, transmit them to relevant parties.

Support regulatory activities in connection with the regulatory regional team.

Qualification Requirements

Master degree (in health sciences is an advantage)

Good understanding of legal/deontological environment in drug safety and regulatory affairs

Demonstrated skills

Strong interpersonal skills, communication, teamwork, project management and pro-activity

Ability to execute tasks in parallel and prioritize broad deliverables

Proficiency in computer skills and database entry

Compliance with all procedural requirements

Demonstrated success in multi-tasking projects

Being customer-oriented service minded and pragmatic

Ability to work effectively and share information within a team environment

Fluent in Dutch and/or French, and English

What we offer

An exciting culture, based on respect for people, striving for excellence and high integrity

A work environment based on collaboration and team spirit

An occasion to be part of a continuous innovating company

The possibility to invest in your personal development

Have a high level of autonomy in your daily activities

A pharma competitive salary & benefit package

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly