Safety Specialist II

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

📋 Description

• Execute all facets of the collection, processing, and reporting of individual case safety reports (ICSR) for clinical trials and/or post-marketing safety initiatives.

• Process ICSRs in accordance with Standard Operating Procedures (SOPs) and specific safety plans for projects/programs.

• Triage ICSRs, assessing ICSR data for completeness, accuracy, and regulatory reportability.

• Input data into the Argus Safety Database.

• Code events, medical histories, concomitant medications, and tests.

• Compose case narratives.

• Evaluate information that requires querying and follow up until the information is acquired and queries are resolved satisfactorily.

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

• Collaborate with data management personnel regarding the reconciliation of 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.

• Engage in audits/inspections as needed.

• Confirm that all pertinent documents are submitted to the Trial Master File (TMF) according to company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs when applicable.

• Maintain understanding and adherence to SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans, and the drug development process.

• Attend departmental meetings.

• Participate in project-specific teleconferences/meetings as required.

• Perform other duties as assigned by management.

⛳️ Requirements

• At least 2 years of experience in clinical trial drug safety within the Pharma/CRO sector.

• Bachelor’s or first-level Degree in Pharmacy or Nursing is preferred; however, qualifications in other Life Sciences or health-related fields are acceptable. Experience with immuno-oncology and Advanced Therapy Medicinal Products is advantageous.

• Familiarity with the Oracle Argus Safety Database.

• Working knowledge of MedDRA and WHODrug.

• Understanding of FDA safety regulations, EMA, MHRA and other ICH guidelines, as well as global safety regulations.

🏝️ Benefits

• Health insurance.

• Flexible work arrangements.