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.

Preferred:

Nursing or pharmacy degree preferred
Clinical trial safety experience
Hands on experience with Argus
Industry experience in CRO or pharmaceutical company preferred

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

$75,600—$113,400 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.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.

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Originally posted on Himalayas

Drug Safety Specialist II - West Coast

Job Description

Position Summary:

Qualifications:

Minimum Required:

Other Required:

Preferred: