Drug Safety Physician (Madrid)

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.
• P...