Drug Safety Physician

hace 5 días

Madrid, España Insud Pharma A tiempo completo

Overview:
**Responsibilities**:
The specific responsibilities include:

- Perform medical assessments of adverse event reports and MedDRA adverse event coding.
- Prepare and/or review of aggregated reports, such as Periodic Safety update Reports, Development Safety Update Reports, Addendums to the Clinical Overviews, Risk Management Plans, among others. Provide input to benefit risk-assessments and Clinical Expert Statement as applicable.
- Review documents related to clinical trials and post-authorization safety studies where the R&D departments and companies of Insud Pharma require support.
- Give medical support to the manufacturing sites when reassessment of the benefit-risk balance of manufactured products is required.
- Provide answers to medical inquiries and prepare benefit risk assessments reports if needed.
- Provision of a medical expert opinion in the medical monitoring, signal detection and risk management activities.
- Participation in the decision-making performed by the Signal Management Team and Signal Detection Committee.
- Provide 24/7 medical assistance to the Qualified Person of Pharmacovigilance (QPPV).
- Collaborate in the establishment of a Quality Pharmacovigilance System for the Medical Safety and Business Support Department within Insud Pharma Global Pharmacovigilance Department.
- Provide medical safety evaluations for the creation and maintenance of product information documents (e.g. Reference Safety Information/Core datasheets/SmPC).
- Collaborate with other departments and business units of Insud Pharma, affiliates, and business partners.
- Collaborate with external key stakeholders as applicable.

Qualifications:

- **Education**: Degree in Medicine. A full and partly completed postgraduate program with a curriculum in pharmacovigilance would be advantageous.
- ** Experience (years/area)**: Hospital medical experience in patient care (e.g. medical residency of internal medicine, clinical pharmacology, or similar) and preferentially some years of experience in a PV Department of a medium-large pharmaceutical company, a CRO or in a hospital setting managing the system of adverse event reporting.
- **Specific Knowledge**:Knowledge of pharmacovigilance vocabulary and current European PV Legislation and Good pharmacovigilance practices (GVP).
- **Languages**:Fluent in Spanish and English. Knowledge of other languages will be an asset**.**:

- ** Travels**: Willing to travel, as required.
- ** Personal skills**:Communication, analytical skills, sense of responsibility, sociable, flexibility

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