Instagram
youtube
Facebook

Drug Safety Physician

Freshers years
Not Disclosed
10 Dec. 11, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Medical Review Officer – Pharmacovigilance

Qualification: BDS/MBBS/MD

Experience: Open to all experience levels

Job Description:

  • Provide medical review, analysis, and guidance throughout the case handling and reporting cycle for ADR Reports related to investigational and marketed products.
  • Write the safety section, including benefit-risk assessments, for Aggregate Reports such as PSURs, CASRs, and PADERs.
  • Offer guidance to Drug Safety Associates regarding the medical aspects of drug safety.
  • Analyze ADRs during ongoing surveillance and signal detection, including independent assessment of safety risks.
  • Participate in Safety review meetings and client meetings.
  • Be accountable for maintaining personal readiness for internal audits or regulatory inspections.

Skills:

  • Strong knowledge of clinical research or pharmacovigilance.
  • Ability to interpret and apply global safety regulations.
  • Good presentation skills.
  • Strong analytical and problem-solving abilities.
  • Excellent verbal and written communication skills.
  • Client-focused approach to work.
  • Excellent organizational and prioritization skills.