Safety & PV Submission Spec II

Collaborate with the Sponsor and internal project management associates on the design, preparation and assembly of the expedited and periodic safety report documents
Participates in project launch activities for safety reporting tasks
Prepares Safety Reporting Plan for safety submissions only projects
Maintain tracking of safety submissions
Provides Sponsor/Customer with expedited and periodic safety report submission status updates, as required
Provides support and advice on expedited and periodic safety report issues to project team/Sponsor as required
Apply safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities
File documents according to project specific requirements (electronically or in hard copy as applicable).
Forward completed safety submission documents to clients and other relevant parties
Acts as a point of contact for regulatory issues related to safety submissions
May be responsible for distributing and monitoring team workload
Fosters constructive and professional working relationships with all project team members, internal and external
Assists in the preparation and participates in internal project review meetings as required
Assists in the tracking and measuring of program/project and team progress through collection of cycle time metrics and other key performance indicators (KPIs), related to submissions.
Participates in audits as required/appropriate
Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
Maintains an understanding and compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process

Qualifications

What we re looking for
Bachelor s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
Experience in a clinical research organization preferred with a minimum of five (5) years Safety and Pharmacovigilance experience required including safety submissions
Safety Database systems experience and knowledge of medical terminology required
In depth understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet.
Ability to work independently and in a team environment
Strong communication, presentation, interpersonal skills, both written and spoken
Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects
Detail oriented with a high degree of accuracy and ability to meet deadlines
Able to make effective decisions
Minimal travel may be required (up to 5%)