Drug Safety Specialist

4 weeks ago

Plainsboro Township, United States Integrated Resources, Inc ( IRI ) Full time

SCHEDULE: 8:30am to 5:00pm


TOP 3 MUST HAVES:

1. 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)

2. A minimum of 2 years of progressively responsible, relevant pharmacovigilance experience (including MedDRA coding and adverse event identification) required

3. Exceptional knowledge of medical and pharmacovigilance terminology required


PURPOSE:

Responsible for the receipt, processing, triage and quality assessment of all inbound safety information, including adverse events and technical complaints, for *** Inc.'s (NNI) 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.


RELATIONSHIPS:

Reports to Patient Safety Management.

Daily internal interactions with personnel from Patient Safety , Medical Information, Field Sales, Customer Complaints Center, Suppliers and Patient Centric Customer Care.

Daily external interactions with patients, caregivers, and health-care professionals.


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 NNI 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


PHYSICAL REQUIREMENTS:

Physical Requirements 0-10% overnight travel required; May require occasional work outside of standard business hours to support special requests/events.


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 NNI 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

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

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