Job summary:
This role is responsible for assisting in the oversight of all operational activities related to drug safety studies, from start-up to closeout. It involves monitoring clinical trial safety vendor activities and supporting key tasks related to case processing management within the Argus Safety Database, ensuring compliance with global clinical safety and pharmacovigilance regulations, as well as the procedures of the Global Patient Safety (GPS) department.
RESPONSIBILITIES:
Technical Responsibilities include but are not limited to:
- Process and evaluate Serious Adverse Events (SAEs) and Adverse Events (AEs) from the time of receipt until case closure in the Argus database, including generating queries, MedDRA coding, and narrative writing.
- Manage and implement a high standard of case quality review to ensure accurate medical safety data documentation with the support of the Drug Safety Physician.
- Perform Safety Study Lead tasks, such as reviewing Investigator Brochures and study protocols, and contributing to IND Annual Reports in collaboration with the Drug Safety Physician. Develop study-specific and program-level safety management plans using templates from CRO. Create, review, and update drug safety forms and templates to align with relevant clinical operation documents (e.g., SAE data collection forms and CRFs).
- Monitor the activities of CROs and partners to ensure compliance with applicable Safety Management Plans (SMPs), Pharmacovigilance Agreements (PVAs), and other contractual obligations.
- Collaborate with Data Management to carry out SAE reconciliation activities per study-specific plans.
- Train new safety staff on the Argus system and case processing.
- Work with other departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure proper collection and management of safety data. Lead cross-functional projects, gather input, and achieve consensus on safety operational topics.
- Develop and/or update Standard Operating Procedures (SOPs), processes, and practices for study lead and SAE case processing activities, in compliance with drug safety and pharmacovigilance regulations and standards.
- Manage and execute personal work effectively to achieve departmental goals.
- Additional duties and responsibilities as assigned.
EDUCATION & EXPERIENCE:
Education/Experience:
- BS/BA degree in a related field with a minimum of 9 years of relevant experience; or
- MS/MA degree in a related field with at least 7 years of relevant experience; or
- Experience/understanding of study management
Experience/The Ideal Candidate:
- BS or MS in Nursing, Pharmacy, or a related clinical degree with at least eight years of clinical experience.
- Experience in the biotech/pharmaceutical industry and/or oncology is preferred.
- Familiarity with the Argus safety database is preferred.
- Experience in processing clinical trial and spontaneous adverse events.
