Safety and PV Submission Specialist - 18 month FTC
- Experience Level
- Experienced (non-manager)
Safety and PV Submission Specialist
Office Based/ Home Based
18 Month – Fixed Term Contract
At Syneos Health we are currently have an 18 month FTC opportunity for a Safety and PV Submission Specialist.
Your role would include the following 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
- 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
The ideal candidate will need the following experience / skills to be considered:
- Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience
- Experience in a CRO/Pharma/Med Device company with a minimum of 5 years’ experience in Safety and Pharmacovigilance (including Safety submissions)
- 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
- Ability to manage time and work independently as well as a team enviornment
- Strong organisational skills
- Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook),TeamShare (or other management/shared content/workspace) and internet.
We have a comprehensive benefits package and offer highly competitive remuneration.
If you have the required experience for this position and are eligible to work in the required location then please apply through our online application.
To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.
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. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. #LI-LM1