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. Provide safety training and oversight for consultants, contractors and/or staff. Review and/or draft standard operating procedures and work instructions.

Assist clients and/or other departmental staff with safety-related reviews and other services. Other duties as assigned.

Qualifications

: Minimum Required: BA/BS degree Minimum 2 years safety experience Other Required: Health care professional Hands on experience with global safety database(s), SAE case processing including narrative writing, and safety reports generation Working knowledge of MedDRA and WHODrug Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations.

Compensation

range for this role.

range takes into account the wide range of factors that are considered in making

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.

decisions are dependent on the facts and circumstances of each case.

Benefits

, life insurance and disability

, parental leave, and paid time off for sick leave and vacation, among other

Reasonable estimate of the current range $75,600 — $113,400 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . 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. com .

Drug Safety Specialist II - West Coast