Safety Specialist II

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Process Individual Case Safety Reports (ICSRs) in accordance with Standard Operating Procedures (SOPs) and specific project or program safety plans.

• Triage ICSRs and assess ICSR data for thoroughness, precision, and regulatory reportability.

• Input data into the Argus Safety Database.

• Code adverse events, medical history, concomitant medications, and tests.

• Compose case narratives.

• Contribute to the timely, consistent, and accurate generation of expedited reports in compliance with relevant regulatory requirements.

• Collaborate with data management teams to reconcile safety data between clinical and safety databases.

• Ensure the distribution of all necessary individual expedited and periodic reports for both clinical and post-marketing projects.

• Participate in audits and inspections as necessary.

• Maintain a thorough understanding and adherence to SOPs, Work Instructions (WIs), global drug/biologic/device regulations, Good Clinical Practices (GCPs), International Council for Harmonisation (ICH) guidelines, Good Vigilance Practices (GVP), project/program plans, and the overall drug development process.

⛳️ Requirements

• A minimum of 2 years of experience in clinical trial drug safety within the Pharma/CRO industry.

• A Bachelor’s degree or a first-level degree in Pharmacy or Nursing is preferred.

• Proficiency with the Oracle Argus Safety Database.

• Familiarity with MedDRA and WHODrug.

• Knowledge of FDA safety regulations, EMA, MHRA, and other ICH guidelines, along with global safety regulations.

🏝️ Benefits

• Precision Medicine Group is an Equal Opportunity Employer.

• Reasonable accommodations are available to facilitate the application process.

• Opportunity to collaborate with global teams.