Renibus Therapeutics Southlake , TX 76092
Posted 2 months ago
Position Summary:
Lead and manage the Clinical Safety Pharmacovigilance (CSPV) function by providing pharmacovigilance expertise regarding the creation, implementation and maintenance of the pharmacovigilance processes, compliance with safety management policies procedures and plans, and ensuring maintenance of the pharmacovigilance system master file.
Key skillsets include GCP knowledge regarding safety reporting and oversight, strong interpersonal skills including written and verbal communication skills, strong organizational skills with attention to detail.
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Department: Clinical Operations
Reports To: Vice President of Clinical Operations
Job Responsibilities
Overall accountability for management of CSPV
Close interaction with other departments; Clinical Operations, Data Management, Research, Regulatory, Quality Assurance, Manufacturing/CMC) and any partners/vendors, as applicable
Oversight of Pharmacovigilance (PV) standards within the CSPV functional area including the management of Standard Operating Procedures, policy documents and processes relevant to PV
Develop, implementation and ongoing management of study-specific Safety Management Plan (SMP) and Case Report Forms
Issuing and resolving safety queries in the study database
Manage accurate and timely safety related regulatory reporting (AEs, SAEs, SUSARs) per study and regulatory requirements including collaboration with regulatory affairs and clinical operations, or overseeing activities of third-party managing safety reporting
Coordinate ongoing medical reviews of safety related events (per study SMP)
Oversight of safety management across clinical studies
Review of adverse event coding in the EDC for accuracy, in collaboration with Data Management
Mentor/Train other staff, contractors, and vendors regarding the pharmacovigilance processes
Maintenance of safety documents to include in the Pharmacovigilance System Master File Management
Overview of Clinical and Safety Pharmacovigilance vendors, or contractors, if applicable
Global and Local compliance Management
Establishes and maintains key Performance Indicators (KPI) for the PV system and continuously monitors the global PV system compliance
Review applicable study reports and statistical outputs as needed
Serves as a contact for any PV matters internally and externally as requested
Other duties as assigned
Skills. Qualifications and Requirements
Bachelor's Degree required, preferably in nursing or life sciences
Minimum of 7 years' experience in PV in the biotechnology/pharmaceutical industry
Knowledge of domestic and international laws, regulations and policies governing pharmacovigilance
Excellent command of English with strong written and oral skills, including experience in medical and regulatory terminology (Medical Dictionary for Regulatory Activities -MedDRA)
In-depth knowledge and skills in the use of database applications, MS Office, and other relevant software
Highly self-motivated individual able to work with minimal supervision
Renibus Therapeutics