Job Description
Position Description:
As the Sr. 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 processes.
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 that 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 area and disease states.
In collaboration the Medical Monitor (MM), and CMO, you will liaise 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 health care 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:
Role maybe office or home based
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