QPPV

Job summary:

• Has an overall responsibility for Pharmacovigilance and risk management activities including but not limited to safety monitoring in post marketing phase.

Responsibilities:

• Acting as a single Pharmacovigilance contact point for the competent authorities on a 24 hour basis and also as a contact point for Pharmacovigilance inspection
• Having an overview of medicinal product safety profiles and any emerging safety concerns
• Safety signal management
• Continuous safety profile monitoring and benefit-risk evaluation of authorized medicinal products and communication about safety concerns to competent authorities in particular notifying changes to the risk - benefit balance of medicinal products
• Ensuring a full and prompt response to any request from the competent authorities he provision of additional information necessary for the benefit-risk evaluation of a medicinal product
• Meeting commitments and responding to requests from competent authorities including provision of correct and complete information
• Interaction between the Pharmacovigilance and product quality defect systems
• Providing input into the preparation of regulatory action in response to emerging safety  concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals) 
• Management of the database.
• Ensure that all PV activities are conducted according to standard procedures for quality control. Also responsible for improvement the quality system through periodic audit.