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Pharmacovigilance Agreement Specialist
2 semanas atrás
Kenvue is currently recruiting for a Pharmacovigilance Alliance Contracting Manager.
About the Role
The position of the Pharmacovigilance Alliance Contracting Manager entails supporting 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.
Key Responsibilities
- 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.
- 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.
- Review and assist where necessary with creating templates or standard wordings on safety related matters and the maintenance of such templates.
- 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.
- 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.
- Provide general ad hoc advice and support for PV contracting (including training).
- 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.
- 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.
- 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.
