Safety Specialist Ii

3-5 years

$72,500 - $108,700 USD

Remote, USA

10 Nov. 18, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Safety Specialist II at Precision for Medicine

About Precision for Medicine
Precision for Medicine is a global leader in precision medicine clinical research services. Our mission is to transform the clinical research and development process for new therapeutics. We specialize in oncology and rare diseases, integrating clinical operations, laboratory expertise, and advanced data sciences to improve therapeutic outcomes. With over 2000 professionals across 35 offices globally, we are committed to accelerating life-changing treatments worldwide. Join us today as a Safety Specialist II!

Position Summary
As a Safety Specialist II, you will play a critical role in the intake, triage, processing, evaluation, and reporting of Serious Adverse Event (SAE) reports, ensuring compliance with regulatory guidelines, SOPs, and project-specific instructions. You will be the primary safety specialist on complex studies, providing expert guidance on pharmacovigilance best practices.

Key Responsibilities

Safety Report Management: Perform SAE intake, triage, data entry, medical coding, expectedness assessments, and compose narratives for Individual Case Safety Reports (ICSRs) in line with regulations and company policies.
Collaboration: Work closely with sponsors, vendors, and internal teams to develop safety collection tools, processes, and reporting systems.
Case Processing: Manage the safety database setup, perform data entry, coding, and follow up to ensure timely and accurate reporting.
Safety Reporting: Prepare safety training materials, review standard operating procedures, and ensure compliance with global safety regulations.
Mentorship & Training: Provide guidance to junior staff and support training initiatives within the team.
Cross-functional Interaction: Participate in the design and implementation of safety reporting plans and provide input on safety-related strategic department initiatives.

Qualifications

Education: A 4-year degree in Pharmacy, Nursing, or a related healthcare/scientific discipline.
Experience: 3-5 years of experience in clinical trials, pharmacovigilance (PV), or drug safety, with hands-on experience in SAE case processing, narrative writing, and safety report generation.
Technical Knowledge: Proficient in MedDRA and WHO Drug coding, with solid knowledge of FDA safety regulations, EMA, ICH guidelines, and global safety standards.
Skills: Strong analytical and problem-solving skills, with the ability to manage multiple complex clinical studies and safety activities independently.

Preferred Qualifications

Oncology & Rare Disease Expertise: Previous experience in oncology or rare disease therapeutic areas is highly desirable.
CRO/Pharma Experience: Experience in a Clinical Research Organization (CRO) or pharmaceutical company.
Advanced Safety Database Knowledge: Expertise in using global safety databases and troubleshooting safety-related issues.

Compensation

Salary Range: $72,500 - $108,700 USD, based on experience and qualifications.
Benefits: This role is eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance, disability benefits, parental leave, and paid time off for sick leave and vacation.

How to Apply
To apply for the Safety Specialist II position, submit your application through our website or contact our recruiting team. We are an equal opportunity employer and do not discriminate based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law.

Join Our Team
At Precision for Medicine, we are transforming the clinical research landscape, one study at a time. Take the next step in your career by applying today to be part of our dynamic team!

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Safety Specialist Ii

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