Safety & PV Specialist I

About This Opportunity

We are representing a confidential biopharmaceutical services organization seeking a Safety & Pharmacovigilance Specialist I in China. Our client works with pharmaceutical and biotech companies to accelerate the delivery of therapies to patients worldwide. This role offers hands-on experience in pharmacovigilance operations, including case processing, regulatory reporting, and safety database management.

Responsibilities

• Enter and track individual case safety reports (ICSRs) in pharmacovigilance quality and tracking systems
• Process ICSRs according to Standard Operating Procedures and project-specific safety plans
• Triage and evaluate ICSR data for completeness, accuracy, and regulatory reportability
• Code adverse events, medical history, concomitant medications, and laboratory tests using appropriate dictionaries
• Compile complete narrative summaries and follow up on queries until resolved
• Generate timely, accurate expedited safety reports in accordance with regulatory requirements
• Perform literature screening and review for safety signals
• Validate and submit product records, including MedDRA coding of indication terms
• Identify and manage duplicate ICSRs
• Conduct quality review of ICSRs
• Ensure appropriate document submission to Trial Master Files and Pharmacovigilance System Master Files
• Maintain compliance with SOPs, global regulations, GCP, ICH guidelines, and GVP
• Participate in audits as required

What We're Looking For

• Education: Bachelor's degree in life sciences, nursing, pharmacy, or equivalent combination of education and experience
• Technical Skills: Experience with safety database systems and knowledge of medical terminology required
• Regulatory Knowledge: Good understanding of clinical trial processes (Phases II-IV) and/or post-marketing safety requirements, ICH GCP, GVP, and pharmacovigilance regulations
• Software Proficiency: Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, and content management systems
• Work Style: Ability to work independently and collaboratively in team environments
• Communication: Excellent written and spoken communication and interpersonal skills
• Organizational Skills: Strong ability to prioritize and manage multiple tasks and projects simultaneously
• Attention to Detail: High degree of accuracy with proven ability to meet deadlines

How We Work With You

When you apply through Get A Job.ai, our talent team will review your qualifications and conduct an initial screening. If there's a strong match, we will submit your profile to our client for consideration. Please do not contact the client directly—all communication and coordination will be managed through our recruitment team to ensure a professional and streamlined process.

Pay

Compensation details will be discussed during the screening process based on your experience and qualifications.

Equal Employment Opportunity: Get A Job.ai is committed to creating an inclusive environment. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability status, or any other protected characteristic.