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 minimal direction of a Safety Lead or other Safety Management
• Advanced knowledge and understanding of Global safety regulations, MedDRA, WHO Drug, and GCP and ICH guidelines.
• Applies more in-depth knowledge of Argus Safety Database,
• Organizes work and priorities effectively with minimal oversight; understand hierarchy of responsibilities.
• Manages timelines, communicate flow and deliverables, and monitor progress.
• Solid knowledge and understanding of FDA safety regulations, EMA, MedDRA, WHO Drug, MHRA and other ICH guidelines, and global safety regulations.
• Solid understanding of clinical trials methodology
• Ability to work collaboratively with others but exhibits self-motivation and able to work independently.
• May resolve Safety related issues and prioritize workload to meet timelines with minimal support from management.
• May work on multiple complex clinical studies and Safety activities.

Minimum Required:

• 4-year college degree, or equivalent experience ideally in Pharmacy, Nursing, scientific or healthcare discipline
• 3-5 years clinical trial, PV/Drug Safety experience
• Working knowledge of GCP/ICH guidelines and the clinical development process

Other Required:

• Health care professional (i.e., RN, BSN, MD, PharmD)
• Hands on experience with global safety database(s), SAE case processing including narrative writing, and safety reports generation.
• Proficient MedDRA and WHO Drug coding
• Solves complex problems using knowledge/skills, precedents and practices.
• Exercises independent judgment within broadly defined practices in selecting approaches and methods for obtaining results.
• Seeks support for some challenges and problems and proposed solutions
• Recognizes appropriate issues for escalation.
• Able to apply advanced Safety Database troubleshooting skills and abilities.
• Demonstrates good judgment in selecting approaches, processes, and techniques for obtaining solutions.
• Strong knowledge of FDA safety regulations, ICH guidelines, and global safety regulations. 

Preferred:

• Oncology and Rare Disease experience
• Industry experience in CRO and/or pharmaceutical company preferred.