Syneos Health Hiring Safety & PV Specialist II Bachelor’s Degree in life science, registered nurse, pharmacist Apply Now
JOB SUMMARY
Performs all aspects of the
collection, processing, and reporting of individual cases safety reports
(ICSR), 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.
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.
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.
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
Only immediate joiners
2 - 4 Years of case processing
experience.
Preferred experience with Legal
Case Processing.
Must have experience on safety
database - Argus.
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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