Adverse Event Reporting Officer

Adelphi Group

13d • Onsite

About The Position

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.

Requirements

• 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 data, package inserts, medical procedures and industry regulations for product safety event reporting and documentations.
• Demonstrated ability to effectively and professionally communicate with managers, clients, customers, mentors, and the general public.
• Exercise discretion and empathy as patients are living with chronic conditions.
• Demonstrable organizational skills and can give clear examples of their ability to multitask and set priorities in a high-pressure environment.
• Recordkeeping, file management and version control are crucial.
• Think quickly, have strong attention to detail, and be able to troubleshoot effectively.
• Demonstrated ability to anticipate hurdles, overcome them quickly and efficiently, and document the outcome and process changes needed is paramount.
• Good understanding of patient privacy laws (HIPAA) as well as disease knowledge and sensitivity.
• 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.
• Ability to comprehend and utilize basic mathematics as well as business statistics to include percentages, ratios, discounts, interest, commissions, and proportions.
• Ability to identify and define problems while applying effective problem-solving skills through collecting data, establishing facts, and drawing valid conclusions.
• Ability to deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Capable of applying industry benchmarks to create standardized practices.
• Regularly required to stand; walk; sit; use hands (to finger, handle, or feel); reach with hands and arms; and talk or hear.
• 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.
• Must have a valid driver’s license.
• 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.
• Basic computer skills, including database data entry, and previous experience with patient communication a must.

Nice To Haves

• Fluency in a foreign language is a plus, but not required.
• Salesforce (preferred)
• Medical background preferred.
• In some instances, a passport may be necessary.

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

Benefits

• Omnicom’s policy requires employees to work in the office for a minimum of three days a week, unless additional in-office days are directed by their agency or manager.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level