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

Lilly; Alessandria; In loco; EUR 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical industry is seeking a Deputy EU Qualified Person for Pharmacovigilance. This role involves fulfilling regulatory requirements, providing strategic advice, and mentoring within the Global Patient Safety team. The ideal candidate will have a medical degree and extensive experience in pharmacovigilance, contributing to the safety and efficacy of medicinal products.

Servizi

Excellent company pension plan

Access to professional growth via Corporate Lilly University

Creative flexibility in responsibilities

Competenze

• At least 5 years’ experience in pharmacovigilance.
• Global focus and residency in the EU/EEA.
• Understanding of quality systems and epidemiology.

Mansioni

• Deputise for the EU QPPV and fulfill legal requirements.
• Provide strategic pharmacovigilance advice.
• Engage in external pharmacovigilance forums.

Conoscenze

Problem-solving

Clinical judgment

Decision-making under pressure

Interpersonal skills

Teamwork

Communication skills

Data-driven

Flexibility

Formazione

Medical degree

Descrizione del lavoro

We’re looking for people who are determined to make life better for people around the world.

Interested? Then become part of our team and start as soon as possible as :

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

What challenges await you?

• Deputise for the European Union QPPV as required and according to delegation, specifically to fulfill the legal and regulatory requirements for the QPPV role in their absence.
• Provide strategic and technical pharmacovigilance advice to Global Patient Safety (GPS), and other regulatory and medical functions within the Medicines Development Unit.
• Play an active role in the GPS Leadership Team, Safety Review Committee (SRC), and other committees as required.
• Provide training, coaching, mentoring, and demonstrate Global Patient Safety expertise and leadership.
• Deputise for the EU QPPV on the Global Product Labelling Committee (GPLC) as required.

Primary Responsibilities

This job description provides a general overview of the job requirements at the time of preparation. The requirements may change over time and may include additional responsibilities. Please consult with your supervisor regarding your actual job responsibilities and any related duties.

Deputise for the EU Qualified Person for Pharmacovigilance

• Fulfill the legal and regulatory requirements for the EU QPPV role as defined by European legislation and guidelines, in the absence of the EU QPPV or as delegated.
• Ensure appropriate coverage with the QPPV, including provision of necessary information.
• Maintain awareness of the evolving EU regulatory environment, provide feedback to GPS leadership, and advise the Medicines Quality Organization as appropriate. Review and provide expert input to EU regulatory submissions, PASS protocols, and actions related to safety concerns, ensuring timely and accurate data submission to authorities.
• Provide QPPV input to GPLC in the absence or delegation of the QPPV.
• Fulfill all other QPPV obligations as per GVP guidelines.
• Participate actively in the GPS Leadership Team, SRC, and other committees, providing strategic and technical advice.
• Offer independent expert opinions on safety issues.
• Maintain links with Global Regulatory Affairs, providing technical consultancy for safety sections of European regulatory submissions and responses.
• Engage in external pharmacovigilance forums and bring shared learning into the organization.
• Provide training, coaching, and mentorship to safety scientists, medical physicians, and other functions as appropriate.
• Assist in recruitment and succession planning, advising on potential candidates as needed.

How do you convince us?

If you have the following career achievements, you bring the best prerequisites:

• Medical degree with clinical experience
• Global focus, residency, and operation in the EU/EEA
• At least 5 years’ experience in pharmacovigilance; understanding epidemiology is important.
• Problem-solving skills, clinical judgment, decision-making under pressure
• Strong influencing, coaching, negotiating skills across various audiences
• Excellent interpersonal, teamwork, writing, presentation, and communication skills
• Data-driven, capable of working effectively in multicultural environments and independently
• Awareness of product safety regulatory environment and ability to translate into company processes
• Broad knowledge of drug development, clinical research, and business needs
• Understanding of quality systems, epidemiology, and benefit-risk methodologies
• Strong networks and focus on shared learning
• Flexibility and willingness to work outside usual hours
• Ability to travel

What can you look forward to with us?

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 beginning, you will have the freedom to contribute and implement your ideas. You can shape your responsibilities independently or as part of cross-functional or self-organized teams.

Further Development: We support our employees’ career development and provide access to professional growth via our "Corporate Lilly University".

Financial benefits: In addition to an attractive salary, we offer an excellent company pension plan and other benefits.

If interested, please apply online via our website. We look forward to your application!

For further questions, contact us at:

Phone: [phone]

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

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