Drug Safety Specialist II

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $75M Private Equity Round on 2015-12

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• 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. • 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.

🎯 Requirements

• BA/BS degree • Minimum 2 years safety experience • 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.

🏖️ Benefits

• Health insurance • retirement savings benefits • life insurance • disability benefits • parental leave • paid time off for sick leave and vacation