Sr. Safety & PV Submission Specialist

Sr. Safety & PV Submission Specialist Responsibilities 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, fostering 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 postmarketing 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 Benefits Company car or car allowance Health benefits, including medical, dental and vision coverage Company match 401(k) plan Eligibility to participate in Employee Stock Purchase Plan Eligibility to earn commissions or bonuses based on company and individual performance Flexible paid time off (PTO) and sick time Salary Range $67,700.00 - $115,100.00 Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. #J-18808-Ljbffr