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Pharmacovigilance Specialist

Application Deadline: December 31, 2018

Location: Schaumburg, ILLINOIS, USA

Job Summary / Overview:

Core member of the safety team responsible for performing post-marketing pharmacovigilance activities within the US, in partnership with PV vendor for US marketed products.

Key Duties & Responsibilities:

  • work with vendor’s Pharmacovigilance team members to ensure the proper and timely regulatory reporting requirements are met for ICSRs and drug safety reports

  • Provides active management of company’s third party who manages and tracks PV and Medical Communications.

  • Inform management of delayed, missing or incomplete items; ensure follow-up and completion of all tasks are performed in a timely manner.

  • Support leadership in maintaining the company’s compliance status, with respect to PV requirements, and ensuring safe patient outcomes for all company customers.

  • Assist in development of procedures, workflows and templates to meet regulatory requirements and company objectives.

  • Audit and Quality Check of individual case report during reconciliation.

  • Perform daily, weekly, and/or monthly reconciliations of adverse event reports with identified partners and programs as required by Pharmacovigilance Agreements

  • Coordinate with team on preparation and submission of Periodic Reports/PADERs.

  • 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.

  • Knowledge of the current Regulations: GCP, FDA, industry guidelines/best practices

  • Participate in the US Pharmacovigilance audits and inspections as needed

  • Monitoring of the US drug safety mailbox

Minimum Qualifications / Experience:

  • Knowledge of Medical Information and pharmacovigilance regulations and guidances

  • Understanding of medical terminology

  • Good organizational skills and the ability to prioritize workload.       Ability to handle multiple tasks and meet pre-determined deadlines

  • Attention to detail

Education / Certifications:

  • This opportunity requires RPh., RN, LPN, or other Licensed Healthcare Professional

Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.

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