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 Principal Safety Specialist?

Position Summary:

Responsibilities will include but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel.

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

Interfacing with sponsors, vendors, and other internal team members in the area of 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
QC of documents and safety reports
Preparation and/or review of project specific safety reporting plans and medical coding plans
Preparation and/or review of safety training materials
Develop and manage standard operating procedures and work instructions
Serve as subject matter expert for department
Provide ongoing training and mentorship for Safety Specialists
Participate in audits and audit preparation, kick-off meetings, and investigator meetings
Participate in bid defenses for existing and potential clients
Assist departmental management with resource management
Assist departmental management with oversight
Serve as project manager for safety standalone projects
Lead departmental initiatives and cross-functional development activities
Assist clients and/or other departmental staff with safety-related reviews and other services

Qualifications:

Minimum Required:

BA/BS degree
10+ years clinical safety experience

Other Required:

Health care professional
Hands on experience with global safety database(s), SAE case processing, and safety reports generation
Working knowledge of MedDRA and WHODrug
Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations

Preferred:

Nursing or pharmacy degree
Industry experience in CRO or pharmaceutical company

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$106,400—$159,600 USD

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

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