Monday , April 22 2024

PPD Job Openings – Principal Safety Specialist

Website PPD

Job Description:

As a Principal Safety Specialist, you will oversee all aspects of pharmacovigilance services for multifaceted projects.

Job Responsibilities:

  • 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.
  • 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.
  • 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.
  • 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.

Job Requirements:

  • Excellent oral and written communication skills including paraphrasing skills
  • Expertise in relevant therapeutic areas as required for processing AEs
  • Solid project management skills with the ability to manage multiple projects simultaneously
  • Proficient at complex clinical study administration including budget activities and forecasting
  • Ability to motivate, mentor and provide guidance to less experience staff
  • Advanced skills in Microsoft Office products (including Outlook, Word, and Excel)
  • Advanced critical thinking and problem-solving skills with ability to evaluate and escalate appropriately
  • Excellent understanding of pathophysiology and the disease process
  • Advanced computer skills with the ability to work within multiple databases
  • Good command of English and ability to translate information into local language where required

Qualification & Experience:

  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
  • Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
  • In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Job Details:

Company: PPD

Vacancy Type:  Full Time

Job Location: Raleigh, NC, US

Application Deadline: N/A

Apply Here

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