Tuesday , April 16 2024

PPD Careers – Principal Safety Specialist

Website PPD

Job Description:

Responsible for the overall planning, co-ordination and delivery of pharmacovigilance services for large, complex projects. Oversee and may perform day-to-day Pharmacovigilance (PVG) activities within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third-party vendors. May directly oversee staff and provide input on individual performance.

Job Responsibilities:

  • Responsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations.
  • Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states.
  • Functions in a lead role. Exercises independent judgment to troubleshoot and resolve project issues and to identify areas for improvement.
  • Serves as primary point of contact in the absence of the manager. Mentors less experienced staff.
  • Participates in/lead departmental initiatives; Serves as a subject matter expert in designated area.
  • Works independently to oversee day-to-day PVG activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.

Job Requirements:

  • Excellent understanding of pathophysiology and the disease process
  • Proficient at complex clinical study administration including budget activities and forecasting
  • Excellent oral and written communication skills including paraphrasing skills
  • Expertise in relevant therapeutic areas as required for processing AEs
  • Ability to motivate, mentor and provide guidance to less experience staff
  • Solid project management skills with the ability to manage multiple projects simultaneously
  • Advanced critical thinking and problem-solving skills with ability to evaluate and escalate appropriately

Job Details:

Company: PPD

Vacancy Type: Full Time

Job Location: Winston-Salem, NC, US

Application Deadline: N/A

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