Product Safety Associate

Pharmaceutical & Healthcare - Plainsboro, NJ

Temporary

PRODUCT SAFETY ASSOCIATE / DATA SAFETY

We are actively seeking a Safety Data Associate with one of the largest pharmaceutical Corporation in the country located in Plainsboro New Jersey.

This is an immediate need. Please review requirements carefully before applying:

REQUIRED QUALIFICATIONS:

  • Bachelor’s degree required, preferably in science or healthcare discipline.
  • A minimum of 2 years Product Safety experience required with Customer Service experience
  • Strong knowledge of medical and pharmacovigilance terminology required
  • MedDRA coding and adverse event identification experience preferred
  • 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
  • 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

JOB DETAILS & FUNCTIONS

Location: Plainsboro, NJ

Duration: 4+ Months Consulting Project

Client Industry: Pharmaceutical

Job Category: Product Safety & Data Safety

Offered hourly pay: $40.00/hr w2

Required years of experience: 2+ years

Degree: BA or BS degree required

Description:

Responsible for the receipt, documentation and initial triage of all inbound safety information,
including serious and non-serious adverse events, replacement for or refund of potentially defective products, and other safety information for companys US marketed products (drugs and devices). 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.

Reports to Product Safety Management
Daily internal interactions with personnel from Product Safety, Medical Information, Field Sales, Supply Chain, Customer Complaints Center and Patient Centric Customer Care.
Daily external interactions with patients, caregivers, health-care professionals and external vendors.

Essential Functions:
Ability to perform all responsibilities of more junior staff, including but not limited to:
- Collect and document information received from inbound and outbound contacts (verbal and written communications) from and to healthcare professionals, sales personnel, patients, caregivers and vendors related to non-serious adverse events and technical complaints associated with products
- Perform data entry of technical complaints and other safety information
- Facilitate customer replacements and refunds; generate acknowledgement letters
- Scan and archive incoming mail containing safety information
- Perform triage, case classification and team assignment
- Handle escalated calls for non-serious adverse events and technical complaints
- Support Case Handling team with reconciliation with vendors and partners
- Assist with training of new hires; mentor new hires
- Call monitoring of Product Safety’s non-serious adverse event calls and Patient Centric Customer Care’s safety calls
- Process feedback from Customer Complaint Center and Clayton
- Quality review of technical complaint reports
- Assist with workload coordination/distribution
- Support the identification of trends and implementation of corrective actions for issues identified during call monitoring, quality review of technical complaint reports, and feedback from Customer Complaint Center and Clayton, NC
- Perform quality checks of cases flagged as incidental/non-cases; support the identification of trends and implementation of corrective actions
- Serve as Subject Matter Expert during audits/inspections for serious and non-serious
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

Job Types: Temporary, Contract

Salary: $35.00 to $40.00 /hour

Experience:

  • Product Safety: 1 year (Required)
  • Quality Assurance: 1 year (Required)
  • Safety Data: 1 year (Required)

Education:

  • Bachelor's (Required)