Senior, Business Process Services

Kenvue Brands LLC; Madrid; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Senior Area Safety Officer to ensure compliance with safety activities across multiple regions. This role involves managing pharmacovigilance responsibilities, collaborating with local health authorities, and overseeing vendor resources. The ideal candidate will have a strong background in the pharmaceutical industry, excellent organizational skills, and the ability to communicate effectively. This position offers a unique opportunity to impact product safety and regulatory compliance in a dynamic environment, making a difference in the lives of millions through everyday care.

Formación

• 3+ years in the Pharmaceutical industry with product vigilance responsibility.
• Sound knowledge of general medicine and clinical practice.

Responsabilidades

• Ensure compliance with local regulations and company policies.
• Manage pharmacovigilance matters with local health authorities.
• Provide oversight of vendor resources across multiple countries.

Conocimientos

Pharmacovigilance

Communication Skills

Organizational Skills

Knowledge of Drug Development

Fluency in English

Knowledge of Portuguese, Italian, or Greek

Educación

University degree in Pharmacy or Healthcare

Herramientas

IT Safety Systems

Descripción del empleo

Kenvue is currently recruiting for : Senior Area Safety Officer . This position reports to the Area Safety Head and is based in Madrid, Spain.

Who we are

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnson's, and BAND-AID Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~22,000 diverse and brilliant people, passionate about insights, innovation, and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact the life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours.

What you will do

The Senior Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies / procedures at local, regional, and global levels and in accordance with any product vigilance agreements with third-party business partners. This role will act as the Local Operating Company (LOC)'s and assigned territories main point of contact for pharmacovigilance matters (including cosmetovigilance, materiovigilance, and nutrivigilance) with the local health authority. They will ensure that appropriate product vigilance and risk management systems are set in place to assure appropriate oversight of products within its responsibility.

Key Responsibilities

• Oversight of the PV System & Overall responsibilities
• Provide oversight of vendor resources within Spain, Andorra, Italy, San Marino, Vatican City, Portugal, Greece, and Cyprus.
• Support the Area Safety Head in providing relevant local information for the European Economic Area / UK Pharmacovigilance System Master Files.
• Perform other agreed tasks assigned by the manager.
• Record self-identified non-conformances and collaborate with the global team to investigate non-conformances while developing and implementing effective Corrective and Preventative Actions (CAPAs).
• Receive and support the Area Safety Head in the responses to safety-related health authority queries.
• Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
• Maintain oversight of proper identification of local literature articles for Adverse Event (AE) reporting as required.
• Perform document management and archiving as required.
• Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
• Perform regulatory monitoring for impact on vigilance activities and responsibilities.
• Collaborate with the global and local teams to notify local health authorities of any safety issues including SSI / ESI and Signals.
• Manage reporting / submissions of safety reports / updates / information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other Kenvue departments as applicable.
• Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetovigilance, materiovigilance, and nutrivigilance, including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements.
• Ensure pharmacovigilance compliance of local company-sponsored programs and research activities as applicable.
• Perform translation for ICSR and PV-related documents, as required.
• Provide technical and strategic input and participate in projects / workstreams led by the Kenvue Medical Safety teams or LOC.
• Develop, update, and implement local procedures to ensure compliance with Kenvue global procedures and national requirements.
• Ensure current knowledge of all relevant company procedures and training.
• Support local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA plans as applicable.
• Management of PV clauses to be included within local agreements.
• Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage).

What we are looking for

Required Qualifications

• University degree in a related field (Pharmacy, Healthcare).
• At minimum 3 years of working experience in the Pharmaceutical industry, within a role with product vigilance responsibility.
• Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific / medical field.
• Proven ability to organize workflow activities.
• Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology.
• Knowledge of global, regional, and local procedural documents as applicable.
• Computer literate with knowledge of relevant IT safety systems.
• Good verbal and written communication skills.
• Ability to establish and maintain open relationships within the organization and with authorities.
• Demonstrable knowledge of all local requirements and of global aspects of product safety.
• Fluency in the English language.
• Knowledge of Portuguese, Italian, or Greek languages would be an advantage.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

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