Safety Specialist II

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won’t you join us today as a Safety Specialist II?

Position Summary:

Responsibilities will include but may not be limited to; for the intake and triage, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) reports according to applicable regulatory guidelines/requirements, Precision for Medicine (PFM) Standard Operating Procedures (SOPs) and project specific instructions.

Independently serves as primary safety specialist on complex studies, applying and providing guidance and safety expertise to clients and team members on Pharmacovigilance best practices tailored to the applicable project, patient population, investigational product and client.

Essential functions of the job include but are not limited to:

• Interfacing with sponsors, vendors, and other internal team members related to drug safety to assist in the design and implementation of safety collection tools, processes, and reporting systems.
• Participate in the assessment and set-up of a safety database to capture SAE data.
• Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures.
• Preparation and/or review of project‑specific safety reporting plans and medical coding plans.
• Preparation and/or review of safety training materials.
• Review and/or draft standard operating procedures and work instructions.
• Mentor or train new PV staff
• May participate (support, review, draft, provide input, etc.) in strategic department development initiatives.
• Perform other duties as assigned.

Qualifications:

• Applies advanced knowledge of the organization, process and structure of clinical studies, PV systems and processes.
• Ability to oversee, manage, and resolve higher level, complex problems and prioritize workload to meet timelines with some support from management.
• Good understanding of technical and content knowledge
• Anticipates case processing needs, identifies, and communicates timelines.
• Responsible for case processing on a broad range of clinical studies under the …