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Pharmacovigilance Associate

Posted on 23.10.2018

Participate in adverse event case management including intake, triage, and processing of cases. Responsible for intake, documentation and response to unsolicited medical information queries. Intake and forwarding of product quality complaints to the Quality Assurance group. Assist in development of procedures, workflows and templates to meet regulatory requirements and company objectives.

ORGANIZATION STRUCTURE

This position does not have any direct reports and will work with global Pharmacovigilance team members to ensure the proper and timely regulatory reporting requirements are met for ICSRs and drug safety reports

RESPONSIBILITIES
Respond to unsolicited medical inquiries, Product Quality complaints and Adverse Events from healthcare professionals, patients/consumers, field staff and other internal business partners, regarding company marketed products, and investigational products.

  • Company standards must be followed and adhered to in respect to follow up and response times.
  • Meet specific project milestones and standards, which include volume, timelines and data quality.
  • Handle initial and follow-up pharmacovigilance ICSRs from consumers, healthcare professionals, attorneys, or investigators, as necessary in accordance with Alvogen policy and procedures.
  • Perform initial triage of cases.
  • Responsible for completion/assignment of expedited cases to ensure regulatory deadlines are met.
  • Coordinate with team on preparation of Periodic Reports/PSURs/DSURs and data lock dates.
  • Inform management of delayed, missing or incomplete items; ensure follow-up and completion of all tasks are performed in a timely manner.
  • Assist overall Adverse Event Management organization in critical tasks on an as needed basis. Tasks include, but are not limited to data entry, follow-up action items, and other various projects.
  • Contribute to the development and revision of standard medical responses, Q & A documents, and other medical information resources
  • Receive, document and respond (verbal and written) to incoming medical information requests from health care professionals, and consumers
  • Evaluate reporting timelines for adverse event reports to prioritize workload.
  • Determine need for, and request, follow-up using appropriate communication methods (eg. fax, email, or telephone).
  • Participate in quality assessment reviews and audits.

 

QUALIFICATIONS

 

  1. This opportunity requires RPh., RN, LPN, or other Licensed Healthcare Professional
  2. Prior call center experience is preferred.
  3. Minimum of 2 year of experience in pharmaceutical industry-based medical information or related discipline including handling of calls on products.
  4. Knowledge of Medical Information and pharmacovigilance regulations and guidances
  5. Understanding of medical terminology, good organizational skills and the ability to prioritize workload
  6. Ability to handle multiple tasks and meet pre-determined deadlines
  7. Computer Skills: Capable with Microsoft suite of programs including Word and Outlook, and the ability to utilize database software. Prior Safety database experience is preferred. 

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