Description
Syneos Health is seeking a Safety & PV Specialist to join their team in India. The successful candidate will be responsible for performing various safety-related tasks, including entering information into PVG quality and tracking systems, triaging ICSRs, evaluating ICSR data, and maintaining safety tracking for assigned activities.
Responsibilities:
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR
- Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans
- Triage ICSRs, evaluate ICSR data for completeness, accuracy, and regulatory reportability
- Maintain safety tracking for assigned activities
- Perform literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required
- Validate and submit xEVMPD product records, including appropriate coding of indication terms using MedDRA
- Identify and manage duplicate ICSRs
- Participate in audits as required
- Foster constructive and professional working relationships with all project team members
Qualifications:
- Bachelor's degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience
- Safety Database systems and knowledge of medical terminology required
- Good understanding of 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