Description
Syneos Health is seeking a Safety & PV Specialist I to join their team. The successful candidate will be responsible for ensuring the quality and timeliness of safety reporting, as well as maintaining compliance with regulatory requirements.
Job Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking of Individual Case Safety Reports (ICSRs)
- Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans
- Evaluate ICSR data for completeness, accuracy, and regulatory reportability
- Code events, medical history, concomitant medications, and tests
- Compile complete narrative summaries
- Identify information to be queried and follow up until information is obtained and queries are satisfactorily resolved
- Assist in the generation of timely, consistent, and accurate reporting of expedited reports
- Maintain safety tracking for assigned activities
- Perform literature screening and review for safety, drug coding, and maintenance of drug dictionary
- Validate and submit xEVMPD product records
- Participate in audits as required
Qualifications
- Bachelor's degree in life science, registered nurse, pharmacist, or an equivalent combination of education and experience
- Knowledge of safety database systems and medical terminology
- Understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements
- Proficiency in Microsoft Office Suite and internet
- Ability to work independently and in a team environment
- Excellent communication and interpersonal skills
- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
Benefits
- Career development and progression opportunities
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Total Self culture allowing authentic self-expression
- Diversity of thoughts, backgrounds, cultures, and perspectives