Syneos Health Hiring Sr Safety Physician – Aggregate Reports

Syneos Health Hiring Sr Safety Physician – Aggregate Reports

16 April, 2022

Job Responsibilities

  • Performs medical review of adverse events reported for both investigational and marketed products
  • Maintains familiarity with MedDRA, WHO-DRL and safety databases such as ARGUS.
  • Works closely with Safety and Pharmacovigilance (SPVG) colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment
  • Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical and post-marketing safety information
  • Identifies, communicates and effectively manages potential safety issues
  • Interacts with client’s safety/medical personnel as appropriate
  • Stays abreast of clinical and drug development information relevant to contracted programs
  • Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports, PSURs, PADERs)
  • Participates in medical safety surveillance/signal detection benefit/risk assessment, and development of trend analyses
  • Participates in the development of REMS and RMP as required
  • Maintains medical and pharmacovigilance expertise through appropriate internal or external continued medical education (CME)
  • Serves as a mentor for other internal safety staff including case processing staff
  • Supports business development activities as required
  • Responsible for performing activities that are in compliance with applicable Corporate Policies, Standard Operating Procedures, Work Instructions and project specific Operating Guidelines
  • Performing other duties as assigned by management.

Qualifications

What we’re looking for

  • The incumbent should possess M.D.,MBBS, D.O.
  • Completed an accredited residency; Minimum of one to two (1 to 2) years of experience in clinical practice
  • Minimum 2+ years of experience in Aggregate Reports, pharmaceutical, biotechnology or device industry working in pharmacovigilance/epidemiology preferred
  • Knowledge of global pharmacovigilance regulations and processes
  • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), safety databases, and internet. .
  • Excellent verbal and written communication skills (proficient in English) as well as in the language required for case processing
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to informand influence
  • Ability to travel as necessary (up to 10%)

Apply through this Link

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