Senior Pv Auditor

buscojobs España; Madrid; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading company in Spain is seeking a Senior PV Auditor to ensure compliance with global pharmacovigilance regulations. The role involves planning and leading audits, analyzing findings, and mentoring junior auditors. Ideal candidates will have extensive experience in pharmacovigilance and strong project management skills.

Formación

• Extensive experience in pharmacovigilance auditing, including US auditing.
• Proven experience in conducting internal and external audits in the pharmaceutical industry.

Responsabilidades

• Plan, conduct, and lead complex pharmacovigilance audits.
• Develop and implement risk-based audit strategies and annual audit plans.
• Write comprehensive audit reports and present findings.

Conocimientos

Analytical Thinking

Communication

Project Management

Risk Assessment

Educación

Bachelor's degree in Pharmacy

Master's degree

Herramientas

PV databases

Auditing tools

Descripción del empleo

We are seeking a highly skilled and experienced Senior PV Auditor to join our team in Spain.

As a key member of our Pharmacovigilance Quality Assurance department, you will play a crucial role in ensuring compliance with global pharmacovigilance regulations and maintaining the highest standards of drug safety practices.

Responsibilities

• Plan, conduct, and lead complex pharmacovigilance audits of internal processes, systems, and external partners
• Plan, conduct and lead contracted audits and QA consultancies requested by our clients, including the client's PV system or their affiliates / partners
• Develop and implement risk-based audit strategies and annual audit plans
• Analyse audit findings, identify trends, and provide recommendations for process improvements
• Write comprehensive audit reports and present findings to senior management
• Collaborate with cross-functional teams to ensure timely closure of audit observations
• Stay current with evolving global pharmacovigilance regulations and industry best practices
• Provide guidance and mentorship to junior auditors and team members
• Participate in regulatory inspections and support responses to regulatory authorities
• Contribute to the development and maintenance of PV quality management systems
• Manage multiple audit projects simultaneously, ensuring timely completion and high-quality deliverables

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or related field; Master's degree preferred
• Extensive experience in pharmacovigilance auditing, including demonstrated experience with US auditing
• In-depth knowledge of global pharmacovigilance regulations and guidelines, including EMA and FDA requirements
• Strong understanding of Good Pharmacovigilance Practices (GVP) and quality management systems
• Proven experience in conducting internal and external audits in the pharmaceutical industry
• Excellent risk assessment and management skills
• Advanced data analysis and interpretation abilities
• Superior report writing and presentation skills
• Strong project management capabilities
• Proficiency in relevant PV databases and auditing tools
• Relevant PV certifications (e.g., RAPS, DIA) are highly desirable
• Exceptional attention to detail and analytical thinking
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team in a fast-paced environment
• Willingness to travel as required for on-site audits (up to 25% of the time), if needed

We look forward to welcoming your application.

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