Area Safety Lead, US, Local Pharmacovigilance

Area Safety Lead, US, Local Pharmacovigilance

Lo que hacemos

En Kenvue, nos damos cuenta del extraordinario poder del cuidado diario. Sobre la base de más de un siglo de herencia y arraigados en la ciencia, somos el hogar de marcas icónicas, incluidas NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® y BAND-AID® que ya conoces y amas. La ciencia es nuestra pasión; El cuidado es nuestro talento.

Quiénes somos

Nuestro equipo global está formado por ~ 22.000 personas brillantes con una cultura laboral en la que cada voz importa y cada contribución es apreciada. Nos apasionan las ideas, innovación y comprometidos con la entrega de los mejores productos a nuestros clientes. Con experiencia y empatía, ser un Kenvuer significa tener el poder de impactar a millones de personas todos los días. Ponemos a las personas en primer lugar, nos preocupamos ferozmente, nos ganamos la confianza de la ciencia y resolvemos con coraje, ¡y tenemos oportunidades brillantes esperándote! Únase a nosotros para dar forma a nuestro futuro y al suyo. Para obtener más información, haga clic en aquí.

Role reports to:

AD Global Consumer Activity Management

Location:

North America, United States, New Jersey, Summit

Lugar de trabajo:

Híbrido

What will you

The Area Safety Lead (United States) 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 a 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 (as applicable) point of contact for pharmacovigilance matters 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

• Maintain up to date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements (for all applicable product classes in the territory) and collaborate with global team to implement process changes required for identification of new requirements

• Support in 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 (Corrective and Preventative Action) plans as applicable.

• Record self-identified non-conformances and collaborate with the global team to investigate non-conformances while developing and implementing effective CAPAs.

• Provide oversight of vendor resources in the countries in scope.

• Act as a delegate for the Area Safety Head, when required.

• Maintain local procedures where applicable and assessing the impact of changes for the global procedure to local procedures.

• Management of PV clauses to be included within local agreements.

• Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.

• Maintain oversight of proper identification of local literature articles for AE reporting as required.

• Perform regulatory monitoring for impact on vigilance activities and responsibilities.

• Ensure reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders) is performed.

• Collaborating with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals.

• Collaborate with the local and global teams to ensure pharmacovigilance compliance of local company sponsored programs and research activities.

• Perform document management and archiving as required.

• Provide technical and strategic input and participate in projects/ workstreams led by the Kenvue Medical Safety teams or LOC.

What We Are Looking For

Required Qualifications

• 4-6 years of pharmaceutical industry experience

• Minimum of bachelor’s degree (health care science professional preferred)

Desired Qualifications

• Experience with vendor resource oversight

• Project management certification/experience preferred

• Ability to organize workflow activities and manage multiple critical issues.

• Excellent verbal and written communication skills.

• Pharmaceutical industry experience including product vigilance responsibility role.

• Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology.

• Computer literate with knowledge of relevant IT safety systems.

• 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.

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What's in it for you

$141,950.00 - $200,400.00

Esto tiene en cuenta una serie de factores que incluyen la ubicación del trabajo, las habilidades del candidato, la experiencia, el nivel de educación y otros factores relacionados con el trabajo.

Kenvue se enorgullece de ser un empleador que ofrece igualdad de oportunidades. Todos los solicitantes calificados recibirán consideración para el empleo basada en el mérito sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, edad, origen nacional o estado de veterano protegido y no serán discriminados por motivos de discapacidad.