Senior Specialist, Pharmacovigilance, Epidemiology & Risk Management

Job Details

• Preparation of responses to PRAC assessment reports and other Authority requests (e.g., referrals, etc).
• Performing signal detection and signal analysis of safety data, provide the appropriate expert advice as well as assisting in communication with regulatory agencies when the new data has an effect on the risk-benefit balance.
• SOP services/writing and review of SOPs, WIs and related documents and training material in the area of pharmacovigilance for clients (including implementation and training.
• Development of customer-specific solutions and processes in cooperation with clients.
• Build, develop and maintain working relationships with clients.
• Ensure client satisfaction and compliance with legal and regulatory requirements.
• Representation of the company and the team with clients, authorities and professional institutions.
• Inform the Head of the Pharmacovigilance Team/Service Line Lead regularly about systematic problems that could jeopardize an appropriate coordination of tasks and to present solutions.
• Management of parts of a project or the complete project.
• Fulfilling highly complex, sophisticated tasks within the area of pharmacovigilance.
• Trigger a non-conformity when any performance deviation from the target KPI (Key Performance Indicator) is detected, issue evaluation and root cause analysis, assign corrective actions with a due date to the most appropriate employee, ensure that all agreed actions are completed by the due date.
• Communicate proactively with clients about the status of the project and provide solutions to address process deviations, quality issues and inefficiencies.
• Development of processes and/or tools within the area of pharmacovigilance in collaboration with the Head of the team and the Head of the Pharmacovigilance Department.
• - Design and prepare Standard Operational Procedures, Working instructions and Client Specifications for Pharmacovigilance processes, ongoing revisions and implementation of updates. Contribute to achievement of departmental goals, Identify and discuss out-of-scope activities that affect project invoicing.
• Client audits (preparation of the audit, defend it, review the audit report and follow action plan). Contribute to resource needs and resource allocation to ensure compliance, identification and implementation of process efficiency needs.
• .Minimum 4 years of experience in relevant field.
• Experience in writing and reviewing PBRER, PSUR, RMP, PADER and ACO
• Experience in Preparation of responses to PRAC, other authority requests
• Experience in writing and review SOP, preparing training material
• Build update and maintain working relationships with client