Job Description

Job Description

Job Description

** Client ** : Large Pharmaceutical Company

** Contract Position ** : 6 months with potential extension if needs allow.

** Title ** : Patient Safety Specialist (Real position: Drug Safety Case Intake Specialist) - 5 POSITIONS OPEN!!!

** Location ** : Plainsboro, NJ - ONSITE - after a while able to work from home a few days.

** Type ** : ONSITE (the worker can work from home few days/ weeks after discussion with the reporting manager, as needed)

** Type of worker ** : W2 is required. No subcontracting.

** Required ** : Bachelor's degree, 2 years experience,

** Advantage, but not required ** : Speaking Spanish

** Job Posting Number: ** 7780

Type of Worker Needed : 2 years relevant experience is required. An entry-to-mid-level pharmacovigilance / drug safety specialist focused on adverse event case processing, safety intake, MedDRA coding, and strong written case documentation.

Soft skills that are helpful : Calm, detail-oriented, and highly collaborative professional with strong written communication, flexibility, and a dependable, process-driven style well suited for accurate pharmacovigilance case work in a fast-paced team environment.

Full Job description:

TARGET START DATE: ASAP DURATION: 6 months SCHEDULE: Mon-Fri 8:30a-5:00p (up to 40 hours/week) TOP 3 “MUST HAVES”:

1. 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).

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

3. 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, for THE COMPANY 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. Manager said to be comfortable working with a team of 10.

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 ad-verse 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

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

SOURCE CALL WITH THE MANAGER ABOUT THIS POSITION:

Familiar with Veeva is best. Argus and ArisG as well are ok. 6 months to start. 2 years exp. Bi lingual Spanish and English. They won't speak in Spanish and English is required. Not a call center role. One or two interviews. Need to fill quickly. Ideal candidates: Know the basics. PV knowledge. How PV works. Great communicating. Flexible. Know case processing experience. Speaking with multiple locations around the world. Onsite in Plainsboro NJ. Responding in written form. The job is writing. Responding. The candidate is comfortable working with a group of 10 people.

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