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Chinese Language Expert - Safety & Pv Specialist I

2+ years
Not Disclosed
10 Jan. 7, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Safety & Pharmacovigilance Specialist I
Location: Remote/Field

About Syneos Health:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We provide clinical, medical affairs, and commercial solutions to address modern market needs. As a part of Syneos Health, you'll collaborate with passionate problem-solvers in a team environment, innovating to help customers achieve their goals. We're committed to simplifying and streamlining our work to deliver therapies faster and improve lives.

Why Syneos Health:
At Syneos Health, we are passionate about career development, offering training, progression, and recognition. We foster an inclusive culture where diversity of thought, background, and perspective is valued. We focus on the total well-being of our employees, creating a place where everyone can thrive.

Job Responsibilities:

  • Enter data into pharmacovigilance (PVG) quality and tracking systems for receipt and tracking of ICSRs (Individual Case Safety Reports).
  • Assist in the preparation of project plans, such as the Safety Management Plan.
  • Set up, deliver, and close out safety and pharmacovigilance projects.
  • Process ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans.
  • Evaluate and triage ICSRs for completeness, accuracy, and regulatory reportability.
  • Code events, medical history, concomitant medications, and tests.
  • Compile narrative summaries and resolve queries related to ICSR data.
  • Generate and submit timely reports in compliance with regulatory requirements.
  • Collaborate with data management teams to reconcile safety data.
  • Perform literature screening, drug coding, and MedDRA coding.
  • Review and maintain safety tracking for assigned activities.
  • Participate in audits and inspections as required.
  • Ensure relevant documents are submitted to the Trial Master File (TMF) for clinical trials and the Pharmacovigilance System Master File for post-marketing programs.

Qualifications:

  • Bachelor's degree in life sciences, registered nurse, pharmacist, or equivalent education/experience.
  • Knowledge of safety database systems and medical terminology.
  • Understanding of clinical trial processes and post-marketing safety requirements, including ICH GCP and GVP guidelines.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, and email systems (Outlook).
  • Excellent communication, organizational, and interpersonal skills.
  • Detail-oriented with the ability to prioritize tasks and meet deadlines.
  • Ability to work independently and within a team environment.
  • Minimal travel required (up to 5%).

Why Work With Us:
Syneos Health offers a dynamic environment where you can challenge the status quo and make a difference in the biopharmaceutical industry. With a presence in over 110 countries, we support global clinical trials and bring therapies to market that improve patient outcomes.

Apply Now:
If this position aligns with your skills and interests, we encourage you to apply. We also invite you to join our Talent Network to stay connected for future opportunities.