PURPOSE :
Responsible for the receipt, processing, triage and quality assessment of all inbound safety information, including adverse events and technical complaints, for 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
- 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
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
- Experience with audits / inspections preferred
- Proficiency in Windows, Microsoft Word, Excel and Outlook required
- Experience with a Call Center and Drug Safety database preferred
- Bi-lingual (Spanish-English) a plus
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