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Safety Processing Associate

Alpha Consulting Plainsboro ,NJ
  • Expired: May 22, 2020. Applications are no longer accepted.

Shift: 8:30a-5p with possible OT on occasion

Project Description:
Responsible for the receipt, processing, triage and quality assessment of all inbound safety information including adverse events and technical complaints for Client's 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 information.

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 Client products into the 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
  • Manage all outbound letters and inbound letters
  • Collect and document information received during outbound follow-up calls
  • Generate acknowledgement and follow-up letters
  • Perform triage, case classification and case assignment
  • Assist with training of new hires; mentor new hires
  • Perform reconciliations
  • Perform quality check of adverse events and associated technical complaints including a review of the case complaint and safety descriptions for completeness, and evaluation and confirmation of case seriousness, review of coding of products, medical history, indications and adverse events, and the final quality check of all case content
  • Provide ongoing feedback regarding case quality to case handlers to support their continued development and ensure excellent case quality
  • Assist with workload coordination
  • 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

Required Skills:
  • Bachelor's degree required (in medical or science-related discipline)
  • A minimum of 2 years of progressively responsible, relevant pharmacovigilance experience Safety (including MedDRA coding and adverse event identification) preferred
  • A minimum of 2 years of Customer Service experience preferred
  • 3 must haves - Must have experience as HCP (healthcare provider); excellent communication skills; some safety experience is preferred but not mandatory
  • Strong knowledge of medical and pharmacovigilance terminology required
  • Knowledge of Client 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

Core Competencies:
Demonstrates values-based competencies in line with the core values that are the foundation of all activities performed by employees in order to achieve the Mission of the Company:
Seek Understanding
  • Seek to understand the thoughts and feelings of self and others
  • Manage self and stay calm even under pressure
  • Demonstrate empathy and take care of others
  • Display an inclusive mindset and respect the diversity in others
Build Teams
  • Ensure a health, engaging and inclusive work environment
  • Build trust and relationships across functions and cultures
  • Recognize and motivate teams for high performance
  • Inspire and support others through times of change
Accelerate Development
  • Actively coach and provide feedback
  • Ensure on-going dialogue about performance and development
  • Provide challenging opportunities to foster growth
  • Identify and develop diverse talents and successors
Set Direction
  • Communicate a compelling purpose and vision with passion and urgency
  • Translate strategy into ambitious goals with clear priorities
  • Make bold decisions and take risk
  • Seek new and innovative solutions
Drive Outcomes
  • Demonstrate agility and adapt quickly to changes
  • Hold self and others accountable
  • Delegate and empower others to take action
  • Keep things simple and eliminate unnecessary complexity

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cindi:



Job Requirements:

Alpha Consulting


Plainsboro, NJ
08536 USA