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Pharmacovigilance Alliance Contracting Manager

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ID:
2507037591W
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Kenvue 目前正在招聘 a：

Pharmacovigilance Alliance Contracting Manager

我们做什么

在 Kenvue，我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础，植根于科学，是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。

我们是谁

我们的全球团队由 ~ 22,000 名才华横溢的员工组成，他们的职场文化中，每个声音都很重要，每一个贡献都受到赞赏。 我们热衷于洞察， 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心，成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本，热切关怀，以科学赢得信任，以勇气解决——有绝佳的机会等着您！加入我们，塑造我们和您的未来。有关更多信息，请单击 here.

Role reports to：

Director, Product Vigilance & Alliance Management

位置：

Latin America, Brazil, Sao Paulo, Sao Paulo

工作地点：

混合

你会做什么

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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