Overview
Safety & PV Specialist I handles pharmacovigilance case processing and safety tracking, including ICSR handling, coding, literature screening, reporting support, and documentation submissions for clinical trials and post-marketing programs.
What you'll do
- Enter and track information into PVG quality and tracking systems for ICSR receipt and tracking.
- Process ICSRs according to SOPs and project/program safety plans.
- Triages ICSRs and evaluate ICSR data for completeness, accuracy, and regulatory reportability.
- Enter safety database data, including coding of events, medical history, concomitant medications, and tests.
- Compile complete narrative summaries and resolve information queries.
- Support timely, consistent, accurate expedited reporting per regulatory requirements.
- Perform literature screening and review for safety and complete MedDRA coding and drug dictionary maintenance as required.
What you'll need
- Bachelor’s degree in life science, registered nurse, pharmacist, or an equivalent combination of education and experience.
- Russian language skill is must-have.
- Approx. 2 years of experience in Safety & Pharmacovigilance related to case processing or safety submissions.
- Safety database systems experience and knowledge of medical terminology.
- Good understanding of clinical trial process across Phases II–IV and/or post-marketing safety requirements, ICH GCP, GVP, and safety/pharmacovigilance regulations.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook email, Team Share (or similar), and internet.
- Excellent written and spoken communication and interpersonal skills.
Details
- Job title: Safety & PV Specialist I (Russian Fluent) – India.
Read the full description and apply on the company’s own careers page.
