Pharmacovigilance Associate II

Job Overview:

We are seeking a detail-oriented and proactive Pharmacovigilance Associate II to support Clinical Trial and Post-Approval Case Processing Activities primarily case follow-up activities. The primary responsibility of this role is to collect and process safety data through outreach to healthcare providers and consumers ensuring compliance with regulatory requirements and internal procedures.

Summary of Responsibilities:

• Managethereceiptandprocessingofalladverseeventreportsreportedeitherspontaneously from any source or from a clinical trial. This includes but is not limited to:
  • Conduct outbound follow up requests to healthcare professionals and consumers to collect post-approval safety data. Outbound requests will be cascaded via email and fax requests.
  • Identifyclinicallysignificantinformationmissingfromthereportsandensure its collection and follow-up.
  • Review adverse event reports for completeness accuracy and expedited reporting requirements.
  • Dataentryofsafetydataontoadverseeventdatabase(s)andtrackingsystems.
  • EnsureallcasesthatrequireexpeditingreportingtoworldwideRegulatoryAgencies and other required parties are processed swiftly and appropriately within required timelines.
• Support additional activities such as data tracking quality control training and data reconciliation.
• Maintainacomprehensive understandingofStandardOperatingProcedures(SOPs)Work Instructions(WI)guidancedocumentsanddirectivesassociatedwithsafetymanagement reporting and pharmacovigilance.
• Supportrootcauseanalysis andCAPAplandevelopment& implementation for identified quality issues as needed.
• Support and/or participate in auditsand inspections including thepreparation as needed.
• Demonstrate role-specific Core Competencies and company values on a consistent and maintain good PSS relationships across functional units.
• Undertake anyotherdutiesasneeded.

Qualifications (Minimum Required):

• Degree in one of the following disciplines: Biological Sciences Pharmacy Nursing Life Sciences
• Associates degree 2 years of safety experience
• BS/BA 2 years of safety experience
• MS/MA 2 years of safety experience
• PharmD 2 years safety experience

Experience (Minimum Required):

• Advanced command of English language including speaking writing and reading.
• Proven expertise in processing U.S. post-approval cases is mandatory
• Proficient with the Argus safety database.
• Strong typing ability and familiarity with Microsoft Office Suite and Windows environment is advantageous.
• Strong attention to detail with a high degree of accuracy.
• Ability to work independently with minimal supervision
• Good understanding of ICH guidelines and global regulatory requirements for the reporting of adverse events for both marketed and investigational products.

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