Senior Medical Safety Advisor

Role & Responsibility

• Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions; (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary
• Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
• Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective
• Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment.
• Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable
• Maintain awareness of medical safety-regulatory industry developments

Qualification (Essential)

• Physician's license (exclude Chinese traditional medicine)
• Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate and/or Residency training can qualify for clinical practice experience
• Japanese language proficiency in speaking, listening, reading and writing (JLPT>N2)
• English language proficiency in reading and writing (e-learning programs will be provided in English)

Qualification (Nice to have):

• Sound knowledge of Medicine
• In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Knowledge of Pharmacovigilance - ICSR and Aggregate reports
• Any experience in clinical trials and pharmacovigilance.
• Adequate Computer skills, especially Microsoft word, excel & PowerPoint
• Good communication skills- verbal and written
• Ability to establish and maintain effective working relationships with managers, co-workers, investigativesite staff, clients and regulatory agency representatives
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

Location:

Homebased

Workstyle Options:

• Full-time (7.5 hours/day)
• Part-time (At least consecutive 3 hours/day * 3 days/week=9 hours/week as minimum)

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.