Adverse Event Reporting Officer in Newcastle upon Tyne

JOB SUMMARY: The Adverse Event Reporting Officer (AERO) is responsible for reporting product safety events to our clients, maintaining appropriate records, and assisting with internal audits. The key transferrable skills for this position are problem solving, professionalism, compassion, communication, organization, the ability to work with minimal supervision, attention to detail, and resourcefulness. Snow’s business is centered around the patient journey, and the AERO must be open, compassionate, and sensitive to the unique life experiences of these patients and caregivers.

Essential Job Functions And Responsibilities:

• Prepare and submit product safety event forms in compliance with Snow standards and individual client requirements.
• Verify the accuracy and completeness of information for each adverse event report in conjunction with the source documents and ensure that the activities are performed in a manner consistent with company SOPs.
• Interact cross functionally to confirm details and request additional information.
• Perform Source Data Verification (SDV) per Snow policies.
• Maintain working knowledge of FDA guidelines for adverse event/special events/product complaints.
• Perform retrospective quality review and document findings, and contribute to metric compilation.
• Assist with technical change processes and conduct quality reviews.
• Assist with risk analysis and corrective actions as identified in internal review of Salesforce and other documentation.
• Suggest improvements, resolve problems, and recommend changes to procedures that will enhance Snow adherence to client and internal processes.
• Recommend changes that will improve quality, efficiency, and reduce cost.

Weekend & Night Work: Snow Companies must report adverse events within 24 hours. Although day-to-day work should take place mostly during regular office hours (8:30 a.m.-6:00 p.m., Monday-Friday), candidates selected for the AERO position should have the expectation that the workload and nature of the work will require hours that extend past the business hours of the company. This includes working in the evening, on the weekends and required rotating Saturday hours.

Flexibility: The core business hours that you work may change based on business needs and shifts may change from time to time.

Collaboration/Teamwork: The expanding size and nature of our company will require that you work in collaboration with people in other departments. Candidates must demonstrate their willingness/ability to step into other roles as needed to drive the success of the company.

Language Skills/Communication: Candidates must have the ability to read and comprehend general documents relating to the pharmaceutical/bio-technology industry. Candidates will have demonstrated their ability to effectively and professionally communicate with managers, clients, customers, mentors, and the general public. Working with patients requires the candidates to exercise discretion and empathy as patients are living with chronic conditions.

Organization: Candidates must have demonstrable organizational skills and can give clear examples of their ability to multitask and set priorities in a high-pressure environment.

Resourcefulness: Product safety event reporting and internal quality assurance monitoring and auditing inherently requires a person to think quickly, have strong attention to detail, and be able to troubleshoot effectively.

Patient Privacy: It is most likely that you will come in contact with Personal Consumer Information (PCI) of patients living with chronic illness. It will be required that you take training courses that include, but are not limited to: Snow Policy Training, Health Insurance Portability and Accountability Act (HIPAA), Adverse Event (AE) Reporting Training, US Food and Drug Administration (FDA) Training.

Computer Skills: Word processors (Word), Spreadsheets (Excel), Presentation software (PowerPoint), Email (Outlook), Internet and World Wide Web, Salesforce (preferred).

Mathematical Skills: Candidate will have the ability to comprehend and utilize basic mathematics as well as business statistics.

Reasoning Ability: Candidate will have the ability to identify and define problems while applying effective problem-solving skills.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment/Environmental Conditions: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Certificates, Licenses & Registrations: Candidates must have a valid driver’s license. In some instances, a passport may be necessary.

Education And Experience: Bachelor's degree (B.A.) from a four-year college or university and/or one to two years of related experience and/or training preferred. Medical background preferred.

Additional Information: Omnicom’s policy requires employees to work in the office for a minimum of three days a week. Our objective is to increase this requirement over time.

Equal Employment Opportunity: It is the policy of Omnicom and any of its affiliates to provide equal employment opportunities to all employees and applicants for employment without regard to race, religion, color, ethnic origin, gender, gender identity, age, marital status, veteran status, sexual orientation, disability, or any other basis prohibited by applicable federal, state, or local law.