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Details
Posted: 28-Dec-22
Location: Cincinnati, Ohio
Salary: Open
Categories:
Academic / Research
Internal Number: 136372
SUBFUNCTION DEFINITION: Apply clinical knowledge to manage the receipt and processing of all adverse event reports in the provision of Pharmacovigilance services. To ensure accurate interpretation and documentation of complex safety data for client products.
REPRESENTATIVE RESPONSIBILITIES
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. Collects, manages, and reviews clinical data from all data sources including but not limited to literature, consumers, healthcare professionals, etc.
Demonstrates problem recognition and effective strategies for communicating the problems to the appropriate resource. Assesses the data with accuracy and consistency identifying trends and issues. Ensures completeness and performs/initiates follow up when needed. Ensures data is managed in accordance with established timelines.
Demonstrates understanding of global safety regulatory requirements and ensures compliance. Develops working knowledge and understanding of safety systems and processes used by client to manage adverse events.
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.
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. Ensures accurate records are maintained (e.g., safety database). Ensures data is managed in accordance with established timelines. Demonstrates problem recognition and effective strategies for communicating the problems to the appropriate resource.
Qualifications
EDUCATION/EXPERIENCE
Required:
Preferred:
Unique Skills:
About Cincinnati Children's Hospital Medical Center
At Cincinnati Children’s, we come to work with one goal: to make children’s health better. We believe in a team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better, and find energy and inspiration in our shared purpose. If you want to be the best you can be, you can do it at Cincinnati Children’s.
More Jobs from This Employer
https://careers.pharmacoepi.org/jobs/17972982/product-safety-specialist-l
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