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Safety Case Manager
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**About the Role**
Job DescriptionWe are seeking a highly skilled Drug Safety Specialist to join our team at TN Portugal. The successful candidate will be responsible for day-to-day adverse events case management, including case intake and follow-up activities in accordance with Global Pharmacovigilance procedures and country regulations.
The role involves managing cases received from designated points of contact, vendors, and business partners for Individual Case Safety Reports (ICSRs), including tracking and translation to English, as well as performing ICSR acknowledgments and reconciliation activities.
The ideal candidate will have a minimum of 1 year of industry experience in pharmacovigilance and/or regulatory affairs, with a general knowledge of PV regulations within their assigned country and expertise in PV processes/activities.
Responsibilities- Manage day-to-day adverse events case management, including case intake and follow-up activities.
- Track and translate Individual Case Safety Reports (ICSRs) to English.
- Perform ICSR acknowledgments and reconciliation activities.
- Execute local PV processes and activities in alignment with PV systems and Quality Management System.
- Reconcile PV cases received from local operating units and contractual partners.
- Support Patient Support Programs (PSP) and/or Market Research vendor(s) related activities.
- File, store, and archive safety-related and regulatory data and documentation.
- Act in full compliance with global and local SOPs and report any deviations or compliance concerns immediately.
