Senior Pharmacovigilance Associate

2 weeks ago


Los Angeles, California, United States PSG Global Solutions Full time

PSG Global Solutions is seeking a Senior Pharmacovigilance Associate, specializing in the Pharmaceuticals and Medical Products sector.


Position Overview:

As a key member of our team, you will be responsible for comprehensive data management of significant adverse events reported from clinical studies, adhering to established workflow protocols and standard operating procedures.

Key Responsibilities:

  1. Conduct thorough data entry for serious adverse events stemming from clinical trials.
  2. Generate precise and detailed case narratives utilizing information from various source documents, including but not limited to case report forms, hospital admission records, history and physical examination notes, progress notes, laboratory results, diagnostic imaging reports, discharge summaries, and autopsy findings.
  3. Formulate appropriate inquiries for missing information or incomplete data, and relay these queries to study site personnel after obtaining approval from a senior Drug Safety representative.
  4. Notify drug safety personnel of any issues concerning case processing, coding, safety databases, or other factors that may affect the quality or timeliness of case processing.
  5. Oversee and document all serious adverse events reported from sponsored clinical trials, prioritizing case processing in accordance with submission deadlines.
  6. Contribute to Drug Safety Department initiatives on an as-needed basis.

Join us in ensuring the highest standards of safety and compliance in drug development.



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