Safety & PV Specialist- Future Roles (India)

Overview

Safety and Pharmacovigilance specialist role supporting the processing, coding and reporting of individual case safety reports (ICSRs) for future roles at Syneos Health in India.

What you'll do

• Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs as required.
• Process ICSRs according to SOPs and project/program-specific safety plans as required.
• Triage ICSRs and evaluate ICSR data for completeness, accuracy, and regulatory reportability.
• Enter data into the safety database.
• Code events, medical history, concomitant medications, and tests.
• Compile complete narrative summaries.
• Identify information to be queried and follow up until queries are satisfactorily resolved.
• Assist in the generation of timely, consistent, and accurate expedited reports in accordance with applicable regulatory requirements.
• Maintain safety tracking for assigned activities.
• Perform literature screening and review for safety, drug coding, maintenance of the drug dictionary, and MedDRA coding as required.
• Validate and submit xEVMPD product records, including appropriate coding of indication terms using MedDRA.
• Manually recode un-recoded product and substance terms arising from ICSRs.
• Identify and manage duplicate ICSRs.
• Perform activities related to SPOR / IDMP.
• Perform quality review of ICSRs.
• Ensure relevant documents are submitted to the Trial Master File (TMF) per company SOP/Sponsor requirements for clinical trials, and to the Pharmacovigilance System Master File for post-marketing programs as appropriate.
• Maintain understanding and compliance with SOPs, Work Instructions, global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.
• Foster constructive and professional working relationships with project team members, internal and external.
• Participate in audits as required or appropriate.
• Apply safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

What you'll need

• Bachelor's Degree in life science, registered nurse, pharmacist, or an equivalent combination of education and experience that gives the necessary knowledge, skills, and abilities to perform the job.
• Safety database systems experience and knowledge of medical terminology required.
• Good understanding of the clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP, and regulations related to safety and pharmacovigilance.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.
• Ability to work independently and in a team environment.
• Excellent communication and interpersonal skills, both written and spoken.
• Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
• Detail oriented with a high degree of accuracy and ability to meet deadlines.

Details

• Location: Gurugram, India.
• This posting is intended for a possible upcoming opportunity rather than a live role; expressing interest adds you to the talent pipeline.