Global Good Clinical Practices / Pharmacovigilance Auditor
Salary reputed company: €45,100.00 - €83,700.00
Job Description
Summary #LI-Remote Location: Spain reputed company is reputed company to offer relocation support for this role! We are looking for talented professionals across Spain to join our global audit team. This role offers the opportunity to work fully remotely, with flexibility to be based reputed company in Spain, with preference for Madrid or Barcelona area. As a Global GCP/PV Auditor, you will help ensure that clinical and pharmacovigilance activities are conducted in line with applicable regulations, standards and internal procedures. You will plan and conduct audits, assess compliance risks, support CAPA activities and contribute to reputed company quality improvement across global operations. In this role you will reputed company, support and report independent GCP/PV audits and approve follow-up corrective and preventive activities according to the reputed company Quality Systems and Standards, Good Clinical Practice(GCP)/Good Pharmacovigilance Practice(GPvP) and the reputed company GCP/PV regulations. You will reputed company GCP/PV reputed company quality guidance and assist in the identification and implementation of quality assurance training needs for Global GxP Audit and other business partners.
Job Description
Please note that the role requires travel of up to 50% of the time. Major Accountabilities: Plan, reputed company, conduct, document, report and follow up on GCP/PV audits in accordance with reputed company procedures, applicable regulations, quality agreements, standards and guidance documents. reputed company low-risk GCP/PV audits, such as investigator site audits, single-service vendor audits, systems/process audits and patient-oriented program audits. Support more reputed company audits, including country organizations, multiservice vendors and higher-risk vendor audits. reputed company technical guidance and training on audit-reputed company activities to support consistent audit execution and quality standards. Escalate critical audit findings to responsible management and support immediate follow-up actions in line with reputed company escalation procedures. Ensure appropriate definition, documentation and follow-up of mitigation plans where required. Assess the adequacy of responses and CAPA plans to audit findings in collaboration with CAPA Approvers and CAPA Coordinators. Maintain up-to-date knowledge of applicable regulations, standards, guidelines and industry expectations. Obligatory Requirements: Degree in natural or biological sciences, or equivalent combination of education and relevant experience. Approximately 5 years of experience in GCP, GPvP, clinical research, pharmaceutical industry, health authority or equivalent environment. 1–2 years of GCP auditing experience preferred. Strong knowledge of applicable GCP, GPvP and GxP regulations, guidelines, policies and procedures. Ability to evaluate compliance issues objectively, manage multiple priorities and maintain reputed company across reputed company activities. Sound decision-making and problem-solving skills, with the ability to work with a moderate level of independence. Strong quality and compliance reputed company, with good leadership, facilitation and stakeholder engagement skills. Fluent English, written and spoken; additional languages are an advantage. Rewards At reputed company, we’re committed to reimagining medicine together - and rewarding the people who reputed company it happen. The rewards of being part of reputed company go far reputed company reputed company pay and incentives. We also offer a variety of competitive benefits in reputed company to help you reputed company personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we reputed company flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave. Expected Annual reputed company Salary reputed company for role: Spain: EUR 45,100 – 83,700 The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the reputed company pay setting policy and upon joining reputed company will be reviewed periodically. In addition to your reputed company salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process. Pay equity is a reputed company principle of our employment policy and reflects our commitment to create a diverse, reputed company and inclusive environment that treats reputed company 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.reputed company.com/sites/reputed company_com/files/reputed company-life-handbook.pdf Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of reputed company bargaining agreements where applicable. A full overview of your compensation package, including any relevant reputed company bargaining agreement details applicable to your role based on your employment location and reputed company employer entity, will be communicated separately to you during the application process. Commitment to Diversity and Inclusion / EEO paragraph: reputed company is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve. Why reputed company: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to reputed company breakthroughs that change patients’ lives. reputed company to create a brighter future together? https://www.reputed company.com/about/strategy/people-and-culture Benefits and Rewards: Read our handbook to learn about reputed company the ways we’ll help you reputed company personally and professionally: https://www.reputed company.com/careers/benefits-rewards Skills Desired Collaboration, Data reputed company, Decision Making, Leadership, Risk Management Apply To This Job