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Pharmacovigilance Alliance Contracting Manager

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Job ID:
2507037591W
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Pharmacovigilance Alliance Contracting Manager

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:

Director, Product Vigilance & Alliance Management

Ubicazione:

Latin America, Brazil, Sao Paulo, Sao Paulo

Luogo di lavoro:

Ibrido

Cosa farai

The responsibility of the Pharmacovigilance Alliance Contracting Manager is to support all regions in monitoring and reviewing contractual agreements that have Pharmacovigilance (PV) implications. To maintain compliance in line with conducting PV according to the legal obligations to be fulfilled under the terms and requirements of Kenvue Medical Safety (KMS) compliance agreements and/or applicable regulatory requirements.

Principle Responsibilities:

1. Maintain oversight and manage the review and drafting where necessary of safety related commercial agreements and supports the inclusion of language for Vendor/Service/Technical agreements.
2. Assist where necessary with negotiations and sign-off of safety related agreements working closely with various internal and external business partners including but not limited to; Safety Operations, PV Legal, Local Safety Officers, Legal, Procurement and Contract Owners.
3. Review and assist where necessary with creating templates or standard wordings on safety related matters and the maintenance of such templates
4. Provide support before and during audits and inspections with respect to safety related agreements. Coordinates effective responses to internal and external audits of pharmacovigilance activities and the corrective actions arising from these audits.
5. Assist with contract database management including but not limited to uploading contracts, periodic review, renewals, terminations, update requests and revisions within the Company Contract Database
6. Provide general ad hoc advice and support for PV contracting (including training).

7. Establish process to ensure involvement of PV function in tracking, review and sign-off of safety related agreements and participate in review of standard operating procedures impacting global contract management.

8. Ensures consistency in global processes by establishing guidelines for clear procedures and overseeing the development of appropriate measures, standard operating procedures and other work practices.

9. Assesses requirements for PSMF Annex B quarterly reports and coordinates production and distribution of annex to key stakeholders. Liaises with QP office, ensures that reporting timelines are met. Prepares and presents metrics for monthly QPPV meeting.

Working Relationship/Interfaces:

  • Liaison with safety organization and local operating companies on safety agreements

  • Liaison with internal/external business partners in negotiating safety agreements

  • Participate in periodic calls with safety groups regional heads, local operating companies/LPV HUB

  • Liaison with internal business partners e.g. safety organizations, local operating companies, Quality Compliance (BRQC), PV legal providing advice, support and training

  • Liaison with BRQC supporting internal audit or inspection requests

Requirements:

  • Prior relevant experience in Medical Safety / Pharmacovigilance in the consumer goods or pharmaceutical segment is required;

  • Prior experience in global structures is required;

  • Prior experience managing people is a plus;

  • A completed bachelor's degree is required;

  • Advanced or fluent English is required;

  • Experience understanding contracts and agreements is required;

  • Sufficient knowledge of MA related Procedures and Guidelines is required.

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