Senior Specialist I, Patient Safety & Pharmacovigilance (Clinical Trial Safety Operations)

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