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Patient Safety Physician
hace 2 semanas
Date:
Mar 13, 2023- City: SFEL - R&D SANT FELIU DE LLOBR
Mission:
Reporting into the Director of Corporate Patient Safety is responsible to support in maintaining a Global Pharmacovigilance system that protects patients and users of Almirall medical solutions performing pharmacovigilance activities to ensure the safety of the assigned Almirall products whilst meeting regulatory requirements worldwide.
Tasks and Responsibilities:
Clinical safety:
- Participates and leads safety related operational activities of clinical trials such as SAE management, reconciliation and unblinding activities when appropriate for individual trials as well as leads DSUR preparation activities.
- Supports and actively contributes to the safety monitoring of investigational medicinal products and participates in regulatory filings and dossiers.
Safety for marketed products:
- Operational support to all postmarketing studies safety related activities including but not limited to ICSR management, reconciliation as well as management of safety monitoring activities.
- Responsible for management of Aggregate Reports (eg.
- Supports in other safety activities such as literature reviews, signal detection activities and maintenance of reference safety information for assigned products.
- Responsible for the preparation and negotiation of PV agreements
- Provides safety input in regulatory activities for marketed products such as renewals and rollout.
- Contributes to the establishment and performance of the Pharmacovigilance Quality Management System, including PSMF maintenance, fulfilling KPIs and GDPR requirements, and implements the procedures required by internal policies and applicable legislation.
- Cooperate in the conduction of internal and external audits and inspections.
Education:
- Life science degree
Specific Knowledge:
- +5 years of experience pharmacovigilance
- Experience in safety activities during clinical development
- English and Spanish fluency required.
- IT knowledge
Values & Competencies:
Competencies:
- Personal accountability
- Ability to work in a crossfunctional environment
Values:
- Care; we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
- Courage; we challenge the status quo, we take full ownership and we learn from our success & failures
- Innovation; we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
- Simplicity; we act decisively and avoid overanalysis, we understand why before we act and we are agile & keep things simple.
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