This role supports Patient Safety and Pharmacovigilance (PSPV) Safety Operations by ensuring the quality, compliance, and timely reporting of safety information from company-sponsored clinical trials, Investigator-Initiated Studies, and expanded access/compassionate use programs.
Responsibilities:- Conduct quality review of clinical trial safety reports to ensure completeness and accuracy of safety data, consistency between source documentation, EDC and safety database records, and compliance with study-specific, internal and global regulatory requirements
- Support review and reconciliation of safety data to ensure investigator/site-reported information is accurately reflected in EDC and safety database
- Generate clinically relevant safety follow-up queries and collaborate with cross functional study teams and CRO to ensure timely resolution, escalating delays or missing information that impact case assessment, evaluation, or regulatory compliance
- Review safety submission documentation, e.g., expedited and aggregate reports, to ensure accurate, complete and timely reporting in accordance with global regulatory requirements
- Support oversight and monitoring activities of PV vendor(s) and provide feedback to support training and process improvement
- Support study-level safety operations activities and other PSPV projects, as assigned
- Assists in the creation/revision of department standard operating procedures and work instructions
- Development and delivery of training for safety related topics
- Support process improvement initiatives and safety systems activities
- Support and participate in audits and inspections, including preparation activities
Preferred Skills, Qualifications and Technical Proficiencies:- Ability to work in a dynamic environment to meet patient and corporate needs
- Knowledge of Argus (or similar safety applications) and EDC systems (e.g., Medidata RAVE)
- Excellent communication and collaboration skills
- Ability to manage multiple projects in a fast-paced environment
- Able to travel for up to 10% of time
Preferred Education and Experience:- Bachelor's degree in healthcare or life sciences - degree such as RN or BSN, PharmD is preferred
- 3 years of PSPV operations experience within a pharmaceutical or biotechnology company
- Candidates without prior PSPV experience will also be considered if they have at least 5 years of direct oncology clinical-study experience such as a Clinical Research Coordinator (CRC), Research Nurse, and/or Clinical Research Associate (CRA)
- Working knowledge of FDA, EU and ICH guidelines for safety reporting for clinical trials
The pay range that the Company reasonably expects to pay for this headquarters-based position is $103,600 - $137,100; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
