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Junior PV Physician

1.00 to 3.00 Years   Mysore   11 Aug, 2019
BioClinica
Job LocationMysore
EducationNot Mentioned
SalaryNot Disclosed
IndustryFMCG / F&B
Functional AreaGeneral / Operations Management
EmploymentTypeFull-time

Job Description

  • Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
  • Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
  • Perform triage of cases and determine seriousness and relatedness across products as assigned
  • Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.
  • Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
  • Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
  • Conduct assessment of litigation cases across products as assigned
  • Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
  • Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
  • Acquire and maintain knowledge of applicable Global Health Authority regulations
  • Perform any other drug safety related activities as assigned.
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Keyskills :
lifecycledrugsafetylifesciencesglobalhealthmedicalreviewadverseeventsteammanagementclinicaltrialspeoplemanagementoliciesprocedures

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