Expected Starting Salary Range: 26.42 - 32.71

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

• General

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.

• Critical Thinking

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.

• Compliance

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.

• Systems & Proce

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.

• Data 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:

• Associates degree in related field. May require clinical license, certification/training

• 2 - 5 years of work experience in a related job discipline

• or equivalent combination of education and experience

Cincinnati Children's is proud to be an Equal Opportunity Employer that values and treasures Diversity, Equity, and Inclusion. We are committed to creating an environment of dignity and respect for all our employees, patients, and families (EEO/AA).