Area Safety Lead, US, Local Pharmacovigilance

Area Safety Lead, US, Local Pharmacovigilance

Cosa facciamo

A Kenvue, ci rendiamo conto dello straordinario potere della cura quotidiana. Costruiti su oltre un secolo di tradizione e radicati nella scienza, siamo la casa di marchi iconici, tra cui NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® che già conosci e ami. La scienza è la nostra passione; la cura è il nostro talento.

Chi siamo

Il nostro team globale è composto da ~ 22.000 persone brillanti con una cultura del posto di lavoro in cui ogni voce conta e ogni contributo è apprezzato. Siamo appassionati di intuizioni, innovazione e impegno a fornire i migliori prodotti ai nostri clienti. Con competenza ed empatia, essere un Kenvuer significa avere il potere di avere un impatto su milioni di persone ogni giorno. Mettiamo le persone al primo posto, ci prendiamo cura di noi, ci guadagniamo la fiducia della scienza e risolviamo con coraggio - e abbiamo brillanti opportunità che ti aspettano! Unisciti a noi per plasmare il nostro futuro e il tuo. Per ulteriori informazioni, fare clic su here.

Role riporta a:

AD Global Consumer Activity Management

Posizione:

North America, United States, New Jersey, Summit

Luogo di lavoro:

Ibrido

Cosa farai

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.

#LI-GC1

Cosa c'è per te

$141,950.00 - $200,400.00

Questo tiene conto di una serie di fattori tra cui il luogo di lavoro, le competenze del candidato, l'esperienza, il livello di istruzione e altri fattori legati al lavoro.

Kenvue è orgogliosa di essere un datore di lavoro per le pari opportunità. Tutti i candidati qualificati saranno presi in considerazione per l'impiego in base al merito, indipendentemente da razza, colore, religione, sesso, orientamento sessuale, identità di genere, età, origine nazionale o stato di veterano protetto e non saranno discriminati sulla base della disabilità.