Senior Specialist, Pharmacovigilance Epidemiology – Risk Management

Role Overview

• Searching literature databases and screening database hits for new safety data on medicinal products, reportable and non-reportable cases and signal detection.
• Writing Periodic Safety Update Reports (PSUR) in PBRER format, Development Safety Update Reports (DSUR), Addendum to the Clinical Overview (ACO), Periodic Adverse Drug Experience Report (PADER) and Clinical Expert Statements.
• Publishing, distribution, archiving and submission of safety reports.
• Preparation of Signal detection reports, including EVDAS screening if applicable.
• Preparation of SARs (Signal Assessment Reports).
• Writing Risk Management Plans (RMPs).
• Identifying safety concerns and providing advice with regard to future risk minimisation activities for the entire life cycle of the product.
• Reviewing the documents, checking for completeness and consistency, and evaluating the report quality.
• 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.

Requirements

• Minimum four years' experience and knowledge in the field of pharmacovigilance
• Good communication skills (written and verbally); capability to communicate issues and propose solutions.
• English business fluent & local language (as appropriate).

Benefits

• Benefit offerings outside the US may vary by country and will be aligned to local market practice.