The position is responsible for assisting with thepreparation and submission of expedited and periodic safety reports toRegulatory Authorities, Ethics Committees and Investigators, adhering to alldata privacy guidelines, Good Clinical Practices (GCPs), Good PharmacovigilancePractice (GVP), regulatory guidelines, company and project / program-
specificprocedures for clinical trials and / or post-marketing safety programs.
Assists with the design, preparation and assembly of the expeditedand periodic safety report documents
Maintains tracking of safety submissions
Fosters constructive and professional working relationships withall project team members, internal and external
Applies safety reporting regulatory intelligence maintained bySyneos Health to all safety reporting activities
Files documents according to project specific requirements(electronically or in hard copy as applicable)
Forwards completed safety submission documents to clients andother relevant parties
Provides support with miscellaneous project tasks related tosafety reporting
Maintains an understanding and compliance with Standard OperatingProcedures (SOPs), Work Instructions (WIs), global drug / biologic / deviceregulations, GCPs, ICH guidelines, and the drug development process
QUALIFICATION REQUIREMENTS(please indicate if preferred’)
Bachelor’sDegree in life science, registered nurse, pharmacist or an equivalentcombination of education and experience that gives the individual the necessaryknowledge, skills and abilities to perform the job.
Safetyand Pharmacovigilance experience preferred
SafetyDatabase systems and moderate medical terminology preferred.
Proficiencyin Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook),TeamShare (or other management / shared content / workspace) and internet.
Abilityto work independently and in a team environment
Abilityto successfully prioritize and work on multiple tasks
Excellentcommunication and interpersonal skills, both written and spoken
Strongorganizational and documentation skills
Detailedoriented with a high degree of accuracy and ability to meet deadlines
Goodknowledge of ICH guidelines and regulations relating to Safety andPharmacovigilance
Able tomake effective decisions and manage multiple priorities