Deputy European Union (Eu) Qualified Person For Pharmacovigilance (M / F / D)

Eli Lilly and Company; Madrid; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

A leading healthcare company seeks a Deputy EU Qualified Person for Pharmacovigilance. In this role, you'll support regulatory compliance, provide expert advice to various functions, and lead training initiatives. Ideal candidates will have a medical degree, clinical experience, and a strong background in pharmacovigilance.

Servicios

Excellent company pension plan

Creative flexibility

Support for professional development

Formación

• Minimum 5 years in pharmacovigilance.
• Clinical experience preferred.
• Understanding of drug safety regulations.

Responsabilidades

• Ensure compliance with EU pharmacovigilance regulations.
• Coordinate with QPPV on safety data submissions.
• Provide strategic advice to regulatory functions.

Conocimientos

Communication

Problem-solving

Decision-making

Educación

Medical degree

Descripción del empleo

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.

Deputy European Union (EU) Qualified Person for Pharmacovigilance (m/f/d)

What challenges await you?

• Deputise for the EU QPPV as required, fulfilling all legal and regulatory obligations in their absence and as delegated.
• Provide strategic and technical pharmacovigilance advice to Global Patient Safety (GPS) and other regulatory and medical functions within the Medicines Development Unit.
• Actively contribute to the GPS Leadership Team, Safety Review Committee (SRC), and other relevant committees.
• Demonstrate GPS expertise and leadership through training, coaching, and mentoring.
• Represent the EU QPPV on the Global Product Labelling Committee (GPLC) as needed.

Primary Responsibilities:

Deputise for the EU Qualified Person for Pharmacovigilance

• Fulfill the legal and regulatory requirements for the EU Qualified Person for Pharmacovigilance (QPPV) role, as defined by current EU legislation and guidelines, in the absence of or as delegated by the EU QPPV.
• Ensure appropriate coordination and coverage with the QPPV, including timely provision of all necessary information to support the role.
• Maintain up-to-date awareness of EU regulatory developments; provide timely feedback to GPS leadership and guidance to the Medicines Quality Organisation as needed.
• Review and contribute expert input to EU regulatory submissions, PASS protocols, and actions related to emerging safety concerns, ensuring effective risk minimisation and compliance with timeliness, accuracy, and completeness of safety data submitted to Competent Authorities and EMA.
• Provide QPPV input to GPLC in the absence of or as delegated by the QPPV, and fulfill all other delegated QPPV responsibilities per Good Pharmacovigilance Practice (GVP) guidelines.
• Actively contribute to the GPS Leadership Team, SRC, GPLC, and other committees as appropriate; offer strategic and technical advice across global regulatory and medical functions.
• Serve as an independent expert on safety issues, maintaining strong links with Global Regulatory Affairs, and offering consultancy on safety-related content in EU submissions, CHMP responses, and product information documents.
• Provide external technical leadership through engagement in pharmacovigilance forums and integrate shared learning into the organization.
• Deliver training, coaching, and mentorship to safety surveillance scientists, Global Patient Safety physicians, clinical researchers, and other relevant medical and regulatory personnel.
• Support recruitment and succession planning by advising on candidates for managerial and physician roles, as requested.

Your Profile:

If you can look back on the following successes in your career to date, you bring the best prerequisites with you:

• Medical degree with clinical experience, ideally with a global perspective and eligibility to work/reside in the EU/EEA.
• Minimum 5 years in pharmacovigilance, with solid understanding of epidemiology, drug safety regulations, and benefit-risk assessment methodologies.
• Proven clinical judgment, problem-solving, and decision-making skills, especially under pressure.
• Excellent communication, coaching, and influencing abilities across diverse stakeholders and seniority levels.
• Strong writing, presentation, and interpersonal skills; effective in team-based and independent work environments.
• Data-driven mindset with familiarity in quality systems and a commitment to continuous learning and shared knowledge.
• Flexible and mobile, willing to work outside standard hours and travel as needed.

Benefits:

Working atmosphere: We treat each other as equals at all levels and value our team spirit – “Eye-To-Eye” working culture.

Creative flexibility: From the very beginning, you will have the freedom to contribute and implement your ideas. You can shape your area of responsibility independently or as a member of cross-functional or self-organised teams.

Further Development: We value to supporting our employees individually in their career development and at the same time guarantee fair access to professional development worldwide via our "Corporate Lilly University".

Financial benefits: In addition to your attractive salary, we offer you the option of an excellent company pension plan and other individual benefits.

Embracing Diversity

Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines. For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves.

Sound like you? Apply now to be a part of our high performing and diverse team. In return, we’ll give you the opportunity to thrive in the role while bringing your authentic self to work.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [e-mail] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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

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.

Lillydoes 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