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Pharmacovigilance Alliance Contracting Manager

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2507037591W
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Pharmacovigilance Alliance Contracting Manager

我們做什麼

在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

我們是誰

我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.

Role reports to：

Director, Product Vigilance & Alliance Management

位置：

Latin America, Brazil, Sao Paulo, Sao Paulo

工作地點：

混合

你會做什麼

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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