Safety Specialist II
Safety Specialist II
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Job Description
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 projectspecific 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 5 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
Preferred:
- Early phase oncology clinical trial experience
Any data provided as a part of this application will be stored in accordance with ourPrivacy CA applicants please also refer to ourCA 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.
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 .
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team hiring managers and a formal interview process.
Required Experience:
Unclear Seniority
Employment Type
Full Time
