Drug Safety Associate

TOP 3 “MUST HAVES”:

• A bachelor’s degree is required (preferably in a medical or science-related discipline); relevant experience may be substituted for the degree when appropriate (e.g., a Registered Nurse with clinical experience).
• A minimum of 2 years of progressively responsible and relevant pharmacovigilance experience, including MedDRA coding and adverse event identification, is required.
• Exceptional knowledge of medical and pharmacovigilance terminology is required

PURPOSE

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.

ESSENTIAL FUNCTIONS

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 ongoing 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

QUALIFICATIONS

• 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
• Exceptional knowledge of medical and pharmacovigilance terminology required
• Knowledge of supported disease states preferred (e.g. diabetes, obesity, hemophilia, growth hormone disorders)
• Experience with audits/inspections preferred
• Analytical thinking skills required
• Proficiency in Windows, Microsoft Word, Excel and Outlook required
• Experience with a Call Center and Drug Safety database preferred