Syneos Health Sr Safety & PV Submission Bachelor’s Degree
in life science, registered nurse, pharmacist or an equivalent combination of
education
JOB SUMMARY
The position is responsible for 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. Responsible for
providing delivery and expertise with minimal oversight. Coordinates workflow
to ensure delivery of project/program. Accountable to the Project Lead at the
project/program level and line manager for deliverables.
JOB 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
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
QUALIFICATION REQUIREMENTS
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
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