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This role is responsible for undertaking specified Pharmacovigilance activities including projects with oversight by their manager or a designated PV colleague.
**Requirements**:
- Healthcare Professionals: Pharmaceuticals, Veterinarians, Bacteriologists etc.
- Desirable 1-2 years of experience in Pharmacovigilance
- English: Advanced level
**Responsabilities**:
- Assists with execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.
- Assists with day-to-day adverse events case management including case intake, tracking, translation to English (as applicable), acknowledgments, and follow-up activities in accordance with PV procedures and country regulations.
- Assists with Individual Case Safety Report (ICSR) Health Authority submissions in accordance with company procedures and health authority requirements, when requested.
- Assists with aggregate safety report submissions to Health Authorities in accordance with company procedures and health authority requirements, when requested.
- Responsible for filing (electronic, paper), storage and archiving safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
- Participates in compliance activities and assists in coordinating the preparation of necessary corrective actions locally for late reports.
- Supports local PV audits and inspections when requested.
- Supports PV self-inspections as required by PV Legislations (where applicable).
- Responsible for reporting adverse experiences or events (AE) or product quality complaints (PQCs)
associated with the use of our company products in compliance with Corporate Policy 01: Patient Safety.
- Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity.
- May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).
- May be assigned responsibility for ensuring appropriate PV language is included in country PV agreements, liaising with Alliance Managers as required, supporting local qualification/due diligence activities and compliance reviews, and assisting in maintenance of the business partner data tracking system.
- May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per department policy and local legislations.
- Support local implementation of applicable business continuity plans (as applicable).
- Performs other activities as requested by their Manager.
- May participate on special projects or rotational assignments within or outside of IPV as part of their professional development.