Description
Syneos Health is seeking a Safety & PV Submission Spec I to assist with the preparation and submission of expedited and periodic safety reports to Regulatory Authorities, Ethics Committees and Investigators.
Job Responsibilities
The position is responsible for assisting with the preparation and submission of expedited and periodic safety reports to Regulatory Authorities, Ethics Committees and Investigators, adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs.
Responsibilities:
- Assists with the design, preparation and assembly of the expedited and periodic safety report documents
- Maintains tracking of safety submissions
- Fosters constructive and professional working relationships with all project team members, internal and external
- Applies safety reporting regulatory intelligence maintained by Syneos 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 and other relevant parties
- Provides support with miscellaneous project tasks related to safety reporting
- 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
- 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.
- Safety and Pharmacovigilance experience preferred
- Safety Database systems and moderate medical terminology preferred.
- 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
- Ability to successfully prioritize and work on multiple tasks
- Excellent communication and interpersonal skills, both written and spoken
- Strong organizational and documentation skills
- Detailed oriented with a high degree of accuracy and ability to meet deadlines
- Good knowledge of ICH guidelines and regulations relating to Safety and Pharmacovigilance
- Able to make effective decisions
- Manage multiple priorities