Area Safety Lead, US, Local Pharmacovigilance

Area Safety Lead, US, Local Pharmacovigilance

Ce que nous faisons

Chez Kenvue, nous réalisons le pouvoir extraordinaire des soins quotidiens. S'appuyant sur plus d'un siècle d'héritage et enraciné dans la science, nous sommes la maison de marques emblématiques - dont NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® et BAND-AID® que vous connaissez et aimez déjà. La science est notre passion ; Le soin est notre talent.

Qui nous sommes

Notre équipe mondiale est composée de ~ 22 000 personnes brillantes avec une culture d'entreprise où chaque voix compte et chaque contribution est appréciée. Nous sommes passionnés par les idées, l'innovation et l'engagement à fournir les meilleurs produits à nos clients. Avec de l'expertise et de l'empathie, être un Kenvuer signifie avoir le pouvoir d'avoir un impact sur des millions de personnes chaque jour. Nous donnons la priorité aux personnes, nous nous soucions farouchement, nous gagnons la confiance grâce à la science et nous résolvons les problèmes avec courage - et nous vous offrons de brillantes opportunités ! Joignez-vous à nous pour façonner notre avenir et le vôtre. Pour plus d'informations, cliquez sur ici.

Role relève à :

AD Global Consumer Activity Management

Location :

North America, United States, New Jersey, Summit

Lieu de travail :

Hybride

Ce que tu vas faire

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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Qu'est-ce que vous y gagnez

$141,950.00 - $200,400.00

Cela prend en compte un certain nombre de facteurs, notamment le lieu de travail, les compétences du candidat, son expérience, son niveau d'éducation et autres facteurs liés à l'emploi.

Kenvue est fier d'être un employeur souscrivant au principe de l'égalité d'accès à l'emploi. Tous les candidats qualifiés seront pris en considération pour un emploi basé sur le mérite, sans égard à la race, la couleur, la religion, le sexe, l'orientation sexuelle, l'identité de genre, l'âge, l'origine nationale ou le statut d'ancien combattant protégé et ne seront pas discriminés sur la base du handicap.