Pharmacovigilance Specialist

2 weeks ago

Lawrenceville, Georgia, United States Net2Source Inc. Full time
Job Title: Pharmacovigilance Specialist

At Net2Source Inc., we are seeking a highly skilled Pharmacovigilance Specialist to join our team. As a key member of our safety team, you will be responsible for leading safety data review teams and participating in related PV and product-development subteams.

Key Responsibilities:

  • Lead Safety Data Review (SDR) Teams and participate in related PV and product-development subteams.
  • Author and contribute to specified PV sections of the PBRERs and DSURs with oversight, as needed.
  • Author responses to safety data queries from health authorities, including coordination and integration of scientific, medical, and regulatory input from various scientific sources and functional groups.
  • Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.
  • Collaborate within and across BMS functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required.

Requirements:

  • Working understanding of medical concepts and some familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.
  • Working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills.
  • Ability to work well in cross-functional teams.
  • Good collaborative and communication skills with scientific subject matter.
  • Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions.

Preferred Qualifications:

  • Good working skills in MS Word, Excel, and PowerPoint, including statistics.

Language: English

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