Drug Safety Physician

Job Description

Qualification: Drug Safety Physician -MBBS , MD in Pharmacology or BDS Experience: Any Job Description: Provide medical review, analysis, and guidance during the case handling and reporting cycle of ADR Reports received for investigational and marketed products Writing of safety section, including benefit-risk assessment of Aggregate Reports such as PSURs, CASRs, and PADERs Provide guidance to Drug Safety Associates in medical aspects of drug safety Analysis of ADRs during ongoing surveillance and signal detection, including independent analysis of safety risks Participate in the Safety review meetings and client meetings Accountable for maintaining personal readiness in response to internal audits or regulatory inspections. Skills: Clinical research or Pharmacovigilance knowledge Knowledge of and ability to interpret and apply global safety regulations. Good Presentation Skills Analytical and problem-solving skills Excellent verbal/written communication skills Client-focused approach to work Excellent organizational and prioritization skills