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Associate Director, Safety Physician
hace 3 meses
Date:18 Jun 2024
Location:
SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain
Company:
Almirall
Mission:
To provide medical scientific input in the corporate pharmacovigilance activities.
To monitor the benefit/risk assessment of the assigned products.
To work in collaboration with members of Corporate Patient Safety and other departments within Almirall.
Tasks and Responsibilities:
- Is responsible for the overview/medical assessment of Individual case safety reports of assigned products.
- Is responsible for the overall medical evaluation of PSURs for assigned products. Answers to PSUR assessment reports to PRAC and RAs and ad hoc pharmacovigilance reports. Manages or writes expert reports of products and responses to regulatory safety queries.
- Performs continuous safety monitoring/safety signal detection activities and evaluation of the risk/benefit ratio for assigned products.
- Maintains the Reference Safety Information (RSI) for assigned products and recommends changes, whenever necessary.
- Assists the Local Safety Officers, partners, CROs in answering medical information questions related to safety for assigned products.
- Participates and provides input in duediligences of new licensingin product acquisitions.
- Participates and provides input in development projects of investigational medicinal products by safety profile evaluation of the products and medical assessment of SUSARs.
- Prepares or manages Risk Management Plan (RMP) elaboration and follow through pharmacovigilance and risk minimisation activities (e.g., PASS studies, DHPC, educational materials, etc).
- Reviews DSURs, participates in safety monitoring committees and meetings.
- Provides safety input in regulatory filing.
Education:
Degree in Medicine
Specific Knowledge:
Specific training/experience in Pharmacovigilance/ Clinical Pharmacology/ Pharmacoepidemiology/ Clinical development.
Basic Statistics knowledge.
General training regarding the Pharmaceutical Industry.
Training on and use of safety databases.
Basic computer skills.
MedDRA dictionary.
Experience:
Minimum 5 years of experience.
Competencies:
- A team player with a positive attitude and the ability to work effectively in matrix teams in a fastpaced environment with changing priorities and a high urgency
- Good communication and stakeholder management skills
- Empowered, with the ability to plan and proactively handle multiple tasks simultaneously
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.
