Manages safety data accurately and efficiently. Collects, manages, and reviews clinical data from all data sources including but not limited to literature, consumers, healthcare professionals, etc. Assesses the data with accuracy and consistency identifying trends and issues. Ensures completeness and performs/initiates follow up when needed. Ensures accurate records are maintained (e.g., safety database). Ensures data is managed in accordance with established timelines.
Demonstrates working knowledge and understanding of safety systems and processes used by client to manage adverse events. Databases include but are not limited to Safety Database, MedDRA, WHO Drug, Document Management Systems, Clinical Database, AE Coding Software. Demonstrates through work, working knowledge of client SOPs and guidelines governing adverse event management.
Demonstrates understanding of global safety regulatory requirements and ensures compliance.
Demonstrates problem recognition and effective strategies for communicating the problems to the appropriate resource.
Works as a team player. Works and communicates effectively with internal and external customers. Communicates well with consumers and health care professionals. Works effectively within a global, multicultural environment. Completes relevant training.
·Health field related knowledge
Demonstrate proficiency in health related field knowledge base.
Ability to work independently, as well as within a team environment
Excellent verbal, written, and interpersonal communication skills.
Demonstrate proficiency with computerized programs.
·Medical Data Comprehension
Demonstrate proficiency to review complex medical data and to summarize data.