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 o...