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Catalyst Clinical Research is seeking a Senior Safety Specialist to oversee safety project management and ensure compliance within their Pharmacovigilance organization. This role involves managing multiple projects, coordinating with clients, and maintaining medical knowledge in relevant therapeutic areas. Candidates require a healthcare degree and substantial experience in the CRO or pharmaceutical sector, particularly in pharmacovigilance.
Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.
Position Description:
As the Senior Safety Specialist (SS), you will be a key member of the Pharmacovigilance (PV) organization, responsible for coordinating and managing contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance. You will work with senior management to develop consistent internal processes and ensure compliance with established procedures.
You will proactively liaise with the Project Manager and clients to ensure optimal performance and utilization of the safety project team. You will manage all aspects of multiple projects, ensuring contractual, procedural, and regulatory requirements are met. This may include serving as back-up for project coverage when needed. You will maintain medical understanding of applicable therapeutic areas and disease states.
In collaboration with the Medical Monitor (MM) and CMO, you will liaise with and establish effective relationships with internal functional team members to implement and manage projects.
Position Qualifications:
Education: Healthcare or life science degree with PV experience; optional licensure as a healthcare professional (MD, RN, RRT, MLT).
Experience: At least 5 years of experience working in a CRO or pharmaceutical company and 3 years of pharmacovigilance experience. Preferred is experience with lifecycle safety, including preparing aggregate reports and literature surveillance.
Required Skills: