Syneos Health is Hiring Safety & PV Specialist II – Literature

Syneos Health is Hiring Safety & PV Specialist II – Literature

9 June, 2022

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.

Qualifications

What we’re looking for

  • 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.
  • 4+ years of working experience in Literature Case processing related activities
  • Should have working experience in Abstract review/extracting data from ICSR related activates
  • experience in Embase database
  • 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
  • Minimal travel may be required (up to 5%)

Apply through this Link

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