Description
Syneos Health is seeking a Safety & Pharmacovigilance Coordinator with 1+ year of experience in CT or literature data entry.
As a Safety & Pharmacovigilance Coordinator, you will monitor and route incoming safety information to the appropriate project teams. You will record all ICSR documentation and track cases in accordance with sponsor/customer specifications, distribute incoming mail and faxes, redact patient-identifying information and images in compliance with data protection guidelines, ICH-GCP, and GVP requirements, and perform accurate and timely data entry into the safety database in accordance with customer-specific guidelines and company standards.
Responsibilities:
- Monitor and route incoming safety information to the appropriate project teams
- Record all ICSR documentation and track cases in accordance with sponsor/customer specifications; distribute incoming mail and faxes
- Redact patient-identifying information and images in compliance with data protection guidelines, ICH-GCP, and GVP requirements
- Perform accurate and timely data entry into the safety database in accordance with customer-specific guidelines and company standards
- Assist with case file creation, tracking, retention, and maintenance (paper and electronic)
- Support management of translation processes for source documents requiring translation
- Assist with query follow-up activities as instructed
- Support safety submission processes as instructed
- Assist with daily workflow reconciliation activities
- Maintain a working knowledge of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP modules, study/program plans, and the drug development process
Qualification Requirements:
- Healthcare professional by education: B.Pharm / M.Pharm / PharmD / BDS
- Minimum 1 year of experience in Pharmacovigilance in a full data entry / case processing role is mandatory
- Experience in processing Literature and Clinical Trial (CT) cases is preferred
- Experience with safety database systems and medical terminology preferred
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, TeamShare (or similar document management systems), and internet applications
- Strong ability to work collaboratively as part of a team
- Ability to prioritize and manage multiple tasks effectively in a fast-paced environment
- Excellent written and verbal communication and interpersonal skills
- Strong organizational and documentation skills with high attention to detail and accuracy
- Should be flexible to work in rotational shifts
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Total Self culture – where you can authentically be yourself