Patient Safety Specialist I

Job Description

Job Summary:

• Responsible for the receipt, processing, triage and quality assessment of all inbound safety information, including adverse events and technical complaints, client US marketed products (drugs and devices) and investigational products.
• Also responsible for ensuring compliance with all internal and external (e.g. FDA) drug and device safety reporting requirements regarding the collection and maintenance of safety records.

Duties and Responsibilities:

Ability to perform all responsibilities of more junior staff, including but not limited to:

• Processing of adverse events and associated technical complaints and analysis results related to marketed products into the local intake, complaint, and global safety databases, including but not limited to:
• Duplicate searches
• Product coding
• MedDRA coding
• Narrative generation
• Labeling assessment according to the current approved product label.
• Receive inbound and make outbound calls for adverse events and technical complaints including handling of refund of replacement requests.
• Perform data entry and review of adverse events and associated technical complaints and provide ongo-ing feedback regarding case quality to other case handlers to support their continued development and ensure excellent case quality.
• Handle incoming and outgoing follow-up correspondence.
• Collect and document information received during outbound follow-up calls.
• Perform triage, case classification and case assignment.
• Handle escalated calls for adverse events and technical complaints.
• Assist with training of new hires; mentor new hires.
• Perform reconciliations.
• Assist with workload coordination/distribution.
• Perform call monitoring.
• Support the identification of trends and implementation of corrective actions for issues identified during case review.
• Coordinate configuration requests for the safety and complaint databases.
• Serve as Subject Matter Expert during audits/inspections for case handling.
• Build customer loyalty by providing high quality customer service.
• Provide professional, accurate and timely responses to product information questions and other inquiries using current approved product labeling and call scripts.
• Identify procedural deficiencies and opportunities for process improvements; make improvement recommendations to management and support implementation of solutions.
• Assist with department related projects.

Education and Experience:

• Bachelor’s degree required (in medical or science-related discipline preferred); relevant experience may be substituted for degree when appropriate (e.g. Registered Nurse with clinical experience).
• A minimum of 2 years of progressively responsible, relevant pharmacovigilance experience (including MedDRA coding and adverse event identification) required
• A minimum of 2 years of Customer Service experience preferred.
• Experience with audits/inspections preferred.

Knowledge, Skills and Abilities:

• Exceptional knowledge of medical and pharmacovigilance terminology required.
• Knowledge of NNI supported disease states preferred (e.g. diabetes, obesity, hemophilia, growth hormone disorders).
• Analytical thinking skills required.
• Proficiency in Windows, Microsoft Word, Excel and Outlook required.
• Experience with a Call Center and Drug Safety database preferred.
• Strong oral and written communication skills required.
• Ability to work with sensitive or confidential information required.
• Strong attention to detail required.
• Ability to handle multiple priorities and demands in a fast-paced environment required.
• Strong planning, organizational and time management skills required.
• Ability to interact with various levels of the organization required.
• Ability to form strong working relationships with stakeholders required.
• Bi-lingual (Spanish-English) a plus.