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

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

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

Safety & PV Coordinator II

Key skills