Contracts Specialist, Governance and Compliance Worker

Viatris Healthcare México S. de R.L. de C.V

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how the Contracts Specialist, Governance and Compliance role will make an impact:
Supports the Pharmacovigilance Contracts function within Product Safety & Risk Management (PSRM). Acts as point of contact within PSRM for functions within Viatris (e.g., Legal, Business Development, Direct Sourcing and Regulatory Affairs) and third parties relating to pharmacovigilance agreements (PVA) in relation to business arrangements in AMERS region. Act as Deputy Affiliate Safety Representative (ASR) in Mexico to ensure compliance to regulation and company procedures.

Responsibilities:
- Ensures pharmacovigilance obligations are consistently and adequately considered in all new/updated/terminated business relationships between Viatris and contractual partners.- Liaises with relevant stakeholders (e.g., Business Development, Legal, Affiliate s, Medical, Marketing) to ensure that Pharmacovigilance Agreements (PVAs) are established where needed.- Reviews contractual business agreements (“Main Agreements”) and determines whether inclusion of Pharmacovigilance language is required and, if yes, whether a distinct PVA is needed.- Negotiates PVAs with Business Partner and ensures that all relevant content changes (compared to the standard laid out in the respective Viatris templates) are approved by the responsible PSRM functions and Legal.- Advises affiliates on the negotiation of local PVAs.- Supports the development and maintenance of procedures, templates and tools used and/or needed for the PVA - business.- Supports the maintenance of the PVA database and retrieval of information from the PVA database.- Collaborates with relevant functions to support effective and timely solutions/responses to compliance issues/questions including audit/inspection findings.- Supports the distribution, communication, and documentation of PVAs and other relevant documents.- Supports the periodic review of PVAs.- Ensures ad hoc updates*, and periodic review of Pharmacovigilance Agreements (PVA). *If provisions of the Main Agreement, regulations, procedures of PSRM or of the contractual partner, or contact details change.- Supports processes for maintenance of the Pharmacovigilance System Master File in accordance with the Good Pharmacovigilance Practice Module II.- Maintains inspection and audit readiness.- Has overview and appropriate understanding of PSRM function processes relevant to the exchange of safety information with the contractual partners.- Supports compliance monitoring activities related to the PSRM PVA function processes.- Perform ASR activities in the absence of the Mexico ASR as per company procedures.- Lead projects assigned by the Lead PSRM Contracts or Regional Manager, PSRM.

Basic Qualifications:
- Bachelor’s degree or equivalent, preferably with related health science background. Advanced degree preferred.- Experience in the understanding, review, and assessment of Business arrangements with Third Parties and placement of Pharmacovigilance Agreements.- Good analytical skills and the ability to organize work in a logical, thorough and succinct manner.- Good command of the English language.- Good negotiation skills.- Knowledge of good documentation practice and quality management systems.- Knowledge of worldwide PV regulatory requirements and industry best practices.- Computer proficient (Windows, Word, Excel) and proficient in specific databases-
- Flexibility to adapt to changing assignments and ability to effectively prioritize.- Good communication skills and ability to work independently and as part of a team.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

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