Syneos Health Safety & PV Specialist II Bachelor’s
Degree in life science, registered nurse, pharmacist or an equivalent
JOB
RESPONSIBILITIES
Enters
information into PVG
quality and tracking systems for receipt and tracking ICSR.
May
assist in the preparation of the Safety Management Plan
Processes
ICSRs according to Standard Operating Procedures (SOPs) and
project/program-specific safety plans.
o Triages
ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report
ability.
o Enters data
into safety database.
o Codes
events, medical history, concomitant medications and tests.
o Compiles
complete narrative summaries.
o Assesses
information to be queried and follows up until information is obtained and
queries are
satisfactorily resolved.
o
Participates in the generation of timely, consistent and accurate reporting of
expedited
reports in
accordance with applicable regulatory requirements.
o Coordinates
with data management staff concerning reconciliation of safety data between the clinical and
safety databases.
Ensures
distribution of all required individual expedited and periodic reports for both
clinical and postmarketing
projects to
the Safety Submissions team if contracted to submit the reports.
Participate in audits/inspections as required
QUALIFICATION
REQUIREMENTS (please indicate if ‘preferred’)
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
Database systems and knowledge of medical terminology required
Good
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
Good
communication and interpersonal skills, both written and spoken
Good
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
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