Associate Director, Pharmacovigilance QA

Novartis; Barcelona; Híbrido; EUR 69.000 - 128.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible/hybrid working options

Descripción de la vacante

Novartis in Barcelona, Spain, is seeking a Senior Pharmacovigilance Quality professional to lead global quality oversight and drive compliance across PV systems. This role focuses on regulatory alignment, continuous improvement, and risk mitigation in a multinational environment.

You will mentor cross-functional teams, support due diligence for acquisitions, and guide investigations and CAPAs to resolution, with a strong emphasis on data integrity and inspections readiness.

Formación

• Degree in Life Sciences or related discipline.
• Excellent written and verbal English.
• Fluency in at least one additional language.
• Significant experience in pharmacovigilance quality, operations, or compliance.
• Strong knowledge of global pharmacovigilance regulations and quality requirements.
• Proven ability to manage complex compliance issues.
• Demonstrated leadership in cross-functional/global environments.

Responsabilidades

• Lead quality oversight of global Pharmacovigilance activities to ensure regulatory compliance.
• Drive quality improvement initiatives strengthening compliance and efficiency.
• Identify compliance risks and provide mitigations to Patient Safety stakeholders.
• Support due diligence activities for product acquisitions and business development opportunities.
• Lead quality activities for mergers, acquisitions, divestments, and system integrations.
• Support maintenance of the Pharmacovigilance System Master File and related quality systems.
• Guide investigations, corrective actions, and preventive actions to resolution.
• Support health authority inspections, inspection readiness activities, and remediation efforts.

Conocimientos

Quality management

Pharmacovigilance experience

Leadership

Regulatory compliance

Cross-functional collaboration

Educación

Life Sciences degree

PharmD/PhD

Descripción del empleo

Salary Range:

€69,100.00 - €128,300.00

Job Description Summary

What if your expertise could help strengthen the systems that protect millions of patients around the world?

Job Description

Location: Barcelona, Spain

#LI-Hybrid

Relocation Support: This role is based in Barcelona, Spain. Novartis is unable to offer relocation support, please only apply if accessible.

Major Accountabilities

• Lead quality oversight of global Pharmacovigilance and Device Vigilance activities to ensure regulatory compliance.
• Drive quality improvement initiatives that strengthen compliance, efficiency, and operational excellence.
• Identify compliance risks and provide mitigation recommendations to Patient Safety stakeholders.
• Support due diligence activities for product acquisitions and business development opportunities.
• Lead quality activities supporting mergers, acquisitions, divestments, and system integrations.
• Support maintenance of the Pharmacovigilance System Master File and related quality systems.
• Guide complex investigations, corrective actions, and preventive action plans to resolution.
• Support health authority inspections, inspection readiness activities, and remediation efforts.
• Provide quality governance and oversight for global pharmacovigilance operational vendors.
• Deputize for the Team Head, providing leadership support and ensuring continuity of critical quality activities.

Essential Requirements

• Degree in Life Sciences or a related scientific discipline.
• Excellent written and verbal communication skills in English.
• Fluency in at least one additional language.
• Significant experience in pharmacovigilance quality, pharmacovigilance operations, or pharmaceutical compliance.
• Strong knowledge of global pharmacovigilance regulations, guidelines, and quality requirements.
• Proven ability to manage complex compliance issues and drive effective resolutions.
• Demonstrated leadership skills with success in cross‑functional and global environments.
• Quality‑focused mindset with strong problem‑solving, decision‑making, and prioritization capabilities.

Additional Desirable Skills

• PharmD, PhD, or other advanced scientific degree is a strong advantage.

Ready to make a difference beyond compliance? Join Novartis and help strengthen the quality systems that safeguard patients worldwide. Bring your expertise, curiosity, and passion for continuous improvement to a global team dedicated to reimagining medicine and delivering better outcomes for people everywhere.

Benefits & Rewards

• We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.
• In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Expected Annual Base Salary Range for role: EUR 69,100.00 - 128,300.00

The base salary offered is determined based on gender‑neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance‑based bonus depending on certain performance parameters. Long‑term equity awards granted at group level may also be part of your package. Further details will be provided during the application process.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering:
https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable.