Senior Medical Safety Advisor
- Employer
- IQVIA
- Location
- Sofia
- Start date
- 15 Apr 2021
- Closing date
- 14 May 2021
View more
- Discipline
- Medical Affairs, Medical Advisor
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
- 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
- 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, Contract, Workstyle:
Homebased, Fixed term contract, Full time
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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.
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