Patient Safety Specialist

3 weeks ago

Plainsboro, United States Novo Nordisk Full time

**About the Department***

The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

**The Position**

Responsible for the receipt, processing, triage and quality assessment of all inbound safety information, including adverse events and technical complaints, for Novo Nordisk 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**

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 substitued 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
- B

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