Medical Regulatory Compliance Specialist
hace 3 días
**About the Role**
We are seeking a highly skilled Medical Regulatory Compliance Specialist to join our Pharmacovigilance Department at our Spanish affiliate. As a key member of the team, you will be responsible for maintaining and improving our pharmacovigilance system, ensuring compliance with regulatory requirements and internal standards.
**Key Responsibilities:**
* Maintain and continuously improve the pharmacovigilance system at the PV Department.
* Perform day-to-day work at the PV department, monitoring PV mailboxes and other communication channels for incoming ICSRs on drugs and parapharmaceuticals.
* Manage ICSR cases and reconcile them with applicable stakeholders.
* Assist in reviewing and aligning PV SOPs and other department's SOPs.
* Participate in audits and inspections, performing local quality and compliance work as needed.
* Identify, negotiate, and establish pharmacovigilance agreements, maintaining them up-to-date.
* Support Corrective Action and Preventive Action (CAPA) plans and continuous improvement work within the PV area.
* Collaborate on Risk Management Plan activities, Direct Healthcare Professional Communications (DHPC), and patient support programs.
**Requirements:**
We require a Bachelor's degree or equivalent in health science, prior experience in PV and case processing of minimum 1-2 years, and fluency in Spanish and English (oral and writing). Strong organizational skills and computer proficiency are essential. If you're excited about this role but your past experience doesn't fully align with every requirement, we encourage you to apply.
**Why Viatris?**
Viatris offers 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.
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