FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Safety & PV Specialist – Future Roles
Syneos Health. Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs .
About the role
Key responsibilities & impact- Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs
- Assist in processing ICSRs according to SOPs and project/program-specific safety plans
- Triage ICSRs and evaluate data for completeness, accuracy, and regulatory reportability
- Enter data into safety databases
- 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 with timely and accurate expedited safety reporting
- Maintain safety tracking for assigned activities
- Perform literature screening and review for safety
- Perform drug coding and maintain drug dictionaries and MedDRA coding
- Validate and submit xEVMPD product records, including coding indication terms using MedDRA
- Manually recode un-recoded product and substance terms from ICSRs
- Identify and manage duplicate ICSRs
- Perform activities related to SPOR/IDMP
- Conduct quality review of ICSRs
- Submit relevant documents to the Trial Master File and Pharmacovigilance System Master File
- Maintain compliance with SOPs, WIs, drug/biologic/device regulations, GCP, ICH guidelines, GVP, project plans, and the drug development process
- Foster professional working relationships with project team members
- Participate in audits
- Apply safety reporting regulatory intelligence to safety reporting activities
Requirements
What you’ll need- Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience
- Safety Database systems knowledge
- Knowledge of medical terminology
- Good understanding of clinical trial processes across Phases II-IV and/or post-marketing safety requirements
- Understanding of ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, Outlook, Team Share or another management/shared content/workspace tool, and internet
- Excellent written and spoken communication and interpersonal skills
- Good organizational skills and ability to prioritize and manage multiple tasks and projects
- Detail orientation, high degree of accuracy, and ability to meet deadlines
- Ability to work independently and in a team environment
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Total Self culture supporting authenticity and employee care
- Diverse and inclusive workplace culture