Pharmacovigilance Alliance Contracting Manager
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- ID:
- 2507037591W
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O que fazemos
At Kenvue, percebemos o extraordinário poder do cuidado diário. Construída com base em mais de um século de herança e enraizada na ciência, somos a casa de marcas icônicas - incluindo NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® que você já conhece e ama. A ciência é a nossa paixão; O cuidado é o nosso talento.
Quem somos
Nossa equipe global é de ~ 22.000 pessoas brilhantes com uma cultura no local de trabalho onde cada voz é importante e cada contribuição é apreciada. Somos apaixonados por insights, inovação e comprometidos em entregar os melhores produtos aos nossos clientes. Com experiência e empatia, ser um Kenvuer significa ter o poder de impactar milhões de pessoas todos os dias. Colocamos as pessoas em primeiro lugar, nos importamos ferozmente, ganhamos confiança com a ciência e resolvemos com coragem - e temos oportunidades brilhantes esperando por você! Junte-se a nós para moldar nosso futuro - e o seu. Para obter mais informações, clique em aqui.
Role reporta para:
Director, Product Vigilance & Alliance ManagementLocalização:
Latin America, Brazil, Sao Paulo, Sao PauloLocal de trabalho:
HíbridoO que você fará
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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