Drug Safety Lead

5-10 years

$113,000 - $152,800 USD

Remote

10 Sept. 3, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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

Join Precision for Medicine as a Drug Safety Lead

About Us:

Precision for Medicine is the world’s first global precision medicine clinical research services organization. We are dedicated to enhancing the clinical research and development process for new therapeutics. Our unique approach combines excellence in clinical operations with laboratory expertise and advanced data sciences to guide every step of the process. We support trials across all stages—from early development to approval—with a focus on oncology and rare diseases. With over 2,000 professionals and 35 offices worldwide, we are poised to accelerate life-changing treatments globally. We invite you to be part of our team as a Drug Safety Lead.

Position Summary:

As a Drug Safety Lead, your responsibilities will include, but are not limited to:

Leading project-specific teleconferences and meetings (e.g., kick-off meetings, internal study-specific meetings, client governance meetings).
Reviewing and approving safety budgets as needed.
Developing safety management plans.
Overseeing serious adverse event (SAE) and suspected unexpected serious adverse reaction (SUSAR) case management from intake to regulatory reporting.
Providing timely safety expertise to team members, clients, and study site personnel.

Key Responsibilities:

Collaborate with sponsors, vendors, and internal teams to design and implement safety collection tools, processes, and reporting systems.
Participate in the assessment and setup of safety databases for SAE data capture.
Perform quality control of documents and safety reports as needed.
Prepare and/or review project-specific safety reporting plans and medical coding plans.
Develop and review safety training materials.
Oversee safety-related budget tasks and activities.
Develop and manage standard operating procedures and work instructions.
Serve as a subject matter expert within the department.
Provide ongoing training and mentorship to Safety Specialists.
Participate in audits, audit preparation, kick-off meetings, and investigator meetings.
Engage in the CAPA management process.
Participate in bid defenses for existing and potential clients.
Assist with resource and departmental management.
Lead safety standalone projects and cross-functional development activities.
Support the generation, tracking, and resolution of SAE/AESI queries.
Provide input and review responses to regulatory agency questions related to safety and pharmacovigilance.
Assist clients and departmental staff with safety-related reviews and services.

Qualifications:

Minimum Requirements:

BA/BS degree.
10+ years of clinical safety experience.
5+ years of pharmacovigilance (PV) experience.

Other Requirements:

Healthcare professional.
Hands-on experience with global safety databases, SAE case processing, and safety report generation.
Working knowledge of MedDRA and WHODrug.
Familiarity with FDA safety regulations, ICH guidelines, and global regulations.
Demonstrated understanding of regulatory agency guidelines for safety reporting and processing in clinical trials.
Experience supporting internal audits and regulatory inspections, including BLA or NDA approval inspections.
Excellent communication and analytical skills (both written and oral).
Ability to explain complex clinical issues clearly and scientifically.
Capable of working in a fast-paced, innovative environment while remaining flexible, proactive, and efficient.

Preferred:

Nursing or pharmacy degree.
Experience in a CRO or pharmaceutical company.
Project management experience.

Compensation:

The estimated compensation range for this role is $113,000 - $152,800 USD. This range considers various factors including skill sets, experience, and organizational needs. Compensation decisions are based on the specifics of each case. This role also includes eligibility for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance, disability benefits, parental leave, and paid time off.

Application Information:

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Equal Opportunity Employer:

Precision Medicine Group is an Equal Opportunity Employer. We make employment decisions without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected characteristics.

Accessibility:

If you need reasonable accommodation to complete the application process or require an alternative method for applying, please contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

Fraud Warning:

Be aware that some individuals or organizations may pose as potential employers with fraudulent job offers. Precision for Medicine will not extend job offers without prior communication with our recruiting team, hiring managers, and a formal interview process.