Syneos Health
Hiring Sr Safety & PV Specialist Bachelor’s Degree in life science, Pharmacist,
JOB
RESPONSIBILITIES
Coordinating
workflow to ensure delivery of project.
Escalates
issues with project deliverables, finance and quality to Safety Program
Delivery
Lead/Manager
or Line Manager as appropriate in a timely manner
Has an
understanding of financial measures, work orders, performance metrics
(including quality parameters, monthly budget reports, and changes in scope)
and project budgets.
Prepares
Safety Management Plan.
Assists in
the preparation and participates in internal project review meetings as
required.
May enter
information into PVG quality and tracking systems for receipt and tracking
ICSR.
May process
ICSRs according to Standard Operating Procedures (SOPs) and project/program
specific safety plans.
Triages
ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report
ability.
Enters data
into safety database.
Codes events,
medical history, concomitant medications and tests.
Compiles
complete narrative summaries.
Assesses
information to be queried and follows up until information is obtained and
queries are satisfactorily resolved.
Participates
in the generation of timely, consistent and accurate reporting of expedited
reports in accordance with applicable regulatory requirements.
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 post marketing projects to the Safety Submissions team if contracted
to submit the reports.
Provides
training of Investigators on ICSR reporting
Participate
in audits/inspections as required
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
understanding and compliance with SOPs, Work Instructions (WIs), global
drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program
plans and the drug development process.
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
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
Minimal
travel may be required (up to 10%)
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