Kenvueは現在、以下求人を募集しております。
Pharmacovigilance Alliance Contracting Manager私たちがしていること
私たちKenvueは、日々のケアが持つ驚くべき力を信じています。100年以上の伝統と科学に根ざし、Neutrogena®, Aveeno®, Tylenol®, Listerine®, Johnson’s® and BAND-AID®など、皆様が既にご存じでご愛用いただいているアイコニックなブランドを提供しています。科学は私たちの情熱であり、ケアは私たちの才能です。
Who We Are
私たちのグローバルチームは、インサイトとイノベーションに情熱を注ぎ、最高の製品をお客様にお届けすることに全力を注ぐ、多様で優秀な22,000人以上の社員で構成されています。専門知識と共感力を備えたKenvuerであることは、毎日何百万人もの人々の生活に影響を与える力を持つことを意味します。私たちは、人を第一に考え、全身全霊をもってケアし、サイエンスで信頼を獲得し、勇気をもって解決します。私たちとあなた自身の未来を、共に切り開いていきましょう。
Role reports to:
Director, Product Vigilance & Alliance Management場所:
Latin America, Brazil, Sao Paulo, Sao Paulo勤務地:
ハイブリッドあなたがすること
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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