Adverse Event Reporting Officer

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, like all positions at Snow, must be open, compassionate, and sensitive to the unique life experiences of these patients and caregivers. The AERO must be able to incorporate the unique patient/caregiver experience into the strategies and solutions we provide to our clients.

ESSENTIAL JOB FUNCTIONS AND RESPONSBILITIES:

To perform this job successfully, the AERO must be able to perform each essential duty within the established guidelines. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• 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
• The primary job functions and responsibilities include, but are not limited to, those listed

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. Candidates will need to demonstrate their ability to be a contributing member of a team that has goals that are broader than an individual job description or function.

Language Skills/Communication:

Candidates must have the ability to read and comprehend general documents relating to the pharmaceutical/bio-technology industry that include, but are not limited to: medical education, medical periodicals, clinical trial data, package inserts, medical procedures and industry regulations for product safety event reporting and documentations. 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. Fluency in a foreign language is a plus, but not required.

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. The importance of privacy means that recordkeeping, file management and version control are crucial.

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. A demonstrated ability to anticipate hurdles, overcome them quickly and efficiently, and document the outcome and process changes needed is paramount. Team members are required to have a good understanding of patient privacy laws (HIPAA) as well as disease knowledge and sensitivity.

Patient Privacy:

The core of our business is working with patients. 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:

Candidate must have excellent computer skills in a Microsoft Windows environment to include:

• 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 to include percentages, ratios, discounts, interest, commissions, and proportions.

Reasoning Ability:

Candidate will have the ability to identify and define problems while applying effective problem-solving skills through collecting data, establishing facts, and drawing valid conclusions. Candidate will have the ability to deal with a variety of concrete variables in situations where only limited standardization exists. Candidate will have the ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Candidate will be capable of applying industry benchmarks to create standardized practices.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands (to finger, handle, or feel); reach with hands and arms; and talk or hear. The employee must regularly lift and/or move up to 25 pounds and occasionally lift and/or move more than 25 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. No or very limited exposure to physical risk.

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. Basic computer skills, including database data entry, and previous experience with patient communication a must.