Senior PV Auditor

PrimeVigilance; Madrid; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Senior PV Auditor to enhance drug safety practices within their Pharmacovigilance Quality Assurance department. In this pivotal role, you will lead complex audits, ensuring compliance with global regulations while mentoring junior team members. Your expertise will drive process improvements and contribute to the development of quality management systems. If you are passionate about maintaining the highest standards in pharmacovigilance and thrive in a dynamic environment, this opportunity is perfect for you.

Formación

• Extensive experience in pharmacovigilance auditing, including US auditing.
• In-depth knowledge of global pharmacovigilance regulations and GVP.

Responsabilidades

• Plan and lead pharmacovigilance audits of internal processes and external partners.
• Develop risk-based audit strategies and present findings to management.

Conocimientos

Pharmacovigilance Auditing

Risk Assessment

Data Analysis

Report Writing

Project Management

Communication Skills

Interpersonal Skills

Educación

Bachelor's degree in Pharmacy

Master's degree in Life Sciences

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.