Clinical Safety Specialist

Overview

At Precision for Medicine, we redefine the way clinical research is conducted. Our unique approach combines innovative technologies with extensive expertise to expedite the development of life-changing therapies, especially in the fields of Oncology and Rare Disease. We are looking for a dedicated Clinical Safety Specialist to join our safety team and play a crucial role in our mission.

• Processing ICSRs in line with Standard Operating Procedures (SOPs) and specific project safety plans.
• Triaging ICSRs and evaluating data for accuracy, completeness, and regulatory compliance.
• Entering and managing data within the Argus Safety Database.
• Coding medical events, medical history, concomitant medications, and laboratory tests.
• Drafting detailed case narratives that accurately represent patient safety data.
• Assessing queries and ensuring follow-up until all relevant information is gathered and discrepancies are resolved.
• Generating timely and precise expedited reports in compliance with regulatory guidelines.
• Collaborating with data management to reconcile safety data between clinical and safety databases.
• Coordinating the distribution of required expedited and periodic reports for both clinical and post-marketing projects.
• Participating in audits and inspections as needed to maintain high safety standards.
• Ensuring all documents are correctly submitted to the Trial Master File (TMF) and the Pharmacovigilance System Master File.
• Maintaining an up-to-date understanding of SOPs, global regulations, Good Clinical Practices (GCPs), and the drug development process.
• Contributing in department meetings and project-specific teleconferences.

Minimum

Required:

• At least 2 years of experience in clinical trial drug safety within the Pharma/CRO industry.
• A Bachelor's degree in Pharmacy, Nursing, or a related life science field is preferred.
• Knowledge of Immuno-oncology and Advanced Therapy Medicinal Products is advantageous.
• Experience with the Oracle Argus Safety Database.
• Understanding of MedDRA and WHO Drug coding.
• Familiarity with FDA safety regulations and ICH guidelines.

Preferred:

• Experience in early phase oncology clinical trials.

Join us at Precision for Medicine to be part of a forward-thinking organization that values your contributions and nurtures your ideas, enabling you to make a significant impact in the realm of clinical safety and patient care.