Pharmacovigilance Quality Assurance Lead - Barcelona, España - Galderma

Galderma

Empresa verificada

Barcelona, España

hace 1 semana

Publicado por:

Isabel García

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Descripción

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries.

We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology.

Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals.

Because we understand that the skin we're in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration.

Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day.

We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future.

Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world.

With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Further supporting our growth and innovation momentum, we are establishing a new Global Capability Center in Barcelona to deploy new capabilities to effectively support its global commercial and functional teams.

Located in the upscale Eixample District in the heart of Barcelona, Galderma's Global Capability Center offers numerous possibilities for professional development such as exposure to global and cross-functional projects and access to global career opportunities.

Job Title:
Pharmacovigilance Quality Assurance Lead

Location:
Barcelona

Key Responsibilities- Audits and Inspections- Support the development and continuous improvement of the Global Pharmacovigilance (PV) system and associated Quality Management System (QMS), including its interfaces with Galderma Affiliates and external partners. Execute the annual audit program by performing PV Audits of Global PV processes, Galderma Affiliates and external partners following a risk-based approach. Carry out independent reviews of PV documentation, including reviews of the PV System Master File (PSMF). In accordance with applicable procedures, inform the EUQPPV, Corporate Compliance unit, Local Safety Officers and, when applicable, Regional PV Heads about any issue that could possibly affect the quality and integrity of the PV system and support applicable remediation actions. Ensure inspection readiness of the PV Quality Management System (Corporate, Affiliates and external partners when required) including preparation, support and follow-up of PV inspections conducted by Competent Authorities. Quality Management System- Participate to the implementation of a Galderma fit for purpose and sustainable PV quality strategy in line with the company goals, expectations, and values. Author or provide input to PV Quality documentation, such as procedures, instructions, and forms. Verify that PV quality processes are implemented and followed in line with current regulatory requirements. Support Corporate PV team members in the investigation of deviations related to PV processes and provide quality input into the development of CAPA plans. Contribute to the quality training of PV employees by developing training materials, facilitating training when necessary or supporting periodic reviews of the global PV training matrix. Participate to the quality reviews of the Global PV system including the analysis of Key Performance Indicators to identify trends. Ensure appropriate documentation of any non-compliance impacting the PV System in an electronic quality management system (Trackwise). Additional activities- Foster a PV quality culture in Corporate and Affiliates organizations by providing advice from a PV quality perspective. Participate to the efficient collaborative platform with the Corporate Compliance unit and other Global PV interfaces (e.g., Quality Systems, Regulatory Affairs, Medical Affairs) ensuring the continuous improvement of Galderma PV system.

Skills & Qualifications- Strong background in Pharmacovigilance and/or Quality Assurance.- Proficient in the Pharmaceutical industry, from which a significant part in Pharmacovigilance and/or Quality Management function.- Experience working in an international matrix environment and proficient in building relationships with stakeholders from multiple functions.

- Experience in leading PV Audits of affiliates