Senior Safety Manager

2 weeks ago

Southlake, United States Renibus Therapeutics Full time

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

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