Safety Agreement Specialist

1 semana atrás

São Paulo, São Paulo, Brasil beBeeCompliance Tempo inteiro R$150.000 - R$190.000

**Job Title:** Pharmacovigilance Alliance Contracting Manager

About the Role

The primary function of this role is to oversee and manage the review and drafting of safety-related commercial agreements. This includes ensuring compliance with regulatory requirements and maintaining accurate records.

Key Responsibilities:
  • Review and draft safety-related commercial agreements, including vendor/service/technical agreements, to ensure compliance with regulatory requirements and company policies.
  • Collaborate with various internal and external stakeholders, including Safety Operations, PV Legal, Local Safety Officers, Legal, Procurement, and Contract Owners, to negotiate and sign off on safety-related agreements.
  • Develop and maintain templates or standard wordings for safety-related matters and ensure their effective use across the organization.
  • Provide support before and during audits and inspections related to safety agreements, coordinating responses to internal and external audit findings and implementing corrective actions as necessary.
  • Manage contract database entries, including uploading contracts, periodic reviews, renewals, terminations, updates, and revisions within the Company Contract Database.
  • Offer general advice and support for pharmacovigilance contracting, including training and development initiatives.
  • Establish processes to ensure involvement of the pharmacovigilance function in tracking, reviewing, and signing off on safety-related agreements and participate in the review of standard operating procedures impacting global contract management.
  • Ensure consistency in global processes by developing guidelines for clear procedures and overseeing the development of appropriate measures, standard operating procedures, and work practices.
  • Coordinate the production and distribution of quarterly PSMF Annex B reports to key stakeholders and prepare metrics for monthly QPPV meetings.

Required Skills and Qualifications:

To excel in this role, you should possess strong analytical, problem-solving, and communication skills. You will also need to demonstrate expertise in pharmacovigilance, contract management, and regulatory compliance. Strong organizational and time-management skills are essential, as well as the ability to work effectively in a team environment and adapt to changing priorities.

Benefits:

This role offers a unique opportunity to contribute to the development and implementation of safety-related agreements that impact millions of people worldwide. As a Pharmacovigilance Alliance Contracting Manager, you will play a critical role in ensuring compliance with regulatory requirements and protecting public health.

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