Description
Syneos Health is seeking a Safety & PV Specialist I (Russian Fluent) to join their team in India.
The successful candidate will be responsible for various safety and pharmacovigilance activities, including:
- Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs
- Assist in processing ICSRs according to SOPs and project-specific safety plans
- Triage ICSRs, evaluate data for completeness, accuracy, and regulatory reportability
- Enter data into safety database, code events, medical history, concomitant medications, and tests
- Compile narrative summaries, identify information to be queried, and follow up until queries are resolved
- Assist in generating timely and accurate reporting of expedited reports
- Maintain safety tracking for assigned activities
- Perform literature screening and review for safety, drug coding, and MedDRA coding
- Validate and submit xEVMPD product records
- Identify and manage duplicate ICSRs
- Participate in audits as required
The ideal candidate will have:
- A Bachelor's degree in life sciences, nursing, pharmacy, or equivalent
- Approximately 2 years of experience in Safety & Pharmacovigilance
- Russian language skills are a must-have
- Knowledge of safety database systems and medical terminology
- Understanding of clinical trial processes and post-marketing safety requirements
- Proficiency in Microsoft Office Suite and other software applications
- Excellent communication and interpersonal skills
Syneos Health offers a dynamic work environment with opportunities for career growth and development.
The salary for this position is not specified.