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Safety & PV Coordinator II
Syneos HealthSafety & PV Coordinator responsible for processing individual case safety reports at Syneos Health. Collaborating with various teams to maintain regulatory compliance and data integrity.
About the role
Key responsibilities & impact- Responsible for assisting with the preparation and processing of individual case safety reports (ICSR)
- Monitor and route incoming information to the appropriate project
- Records all ICSR documentation and tracks them in accordance with sponsor specifications; distributes incoming mail and faxes
- Redacts patient identifying information/images in accordance with data protection guidelines and ICH GCPs and GVP
- Enters data into the safety database in accordance with sponsor-specific guidelines and company standards
- Performs file creation, tracking, retention, and maintenance (paper and electronic)
- Manage the translation process for any source documents requiring translation
- Requests follow-up safety information as appropriate
- Assists with preparing study specific forms/templates
- Assist with submission processes as instructed
- Assist with daily workflow reconciliation
- Maintains understanding of SOPs, WIs, global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process
Requirements
What you’ll need- Bachelor’s Degree in life sciences
- 2+ years of experience in safety/clinical field and knowledge of ICSR case processing/drug coding flow
- Advanced MedDRA coding training and signal detection management experience preferred
- Safety Database systems and medical terminology preferred
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet
- Works with others as part of a team
- Excellent communication and interpersonal skills, both written and spoken and good English level
- Strong organizational and documentation skills
- Detailed oriented with a high degree of accuracy
Benefits
Comp & perks- We are passionate about developing our people, through career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Committed to building an inclusive culture
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Data EntryDocument ManagementDrug Coding FlowSignal Detection ManagementPatient Data Redaction
Soft Skills
Excellent CommunicationInterpersonal SkillsOrganizational SkillsAttention to Detail