[All remote jobs](https://jobicy.com/jobs.md)[![Precision Medicine Group logo](https://jobicy.com/data/server-nyc0409/galaxy/mercury/2025/06/f1277044-221.jpg)](https://jobicy.com/company/precision-medicine-group.md)[Precision Medicine Group](https://jobicy.com/company/precision-medicine-group.md) # Safety Specialist/Safety Lead Review the role, location requirements, compensation details, and application process before deciding whether this opportunity fits your next career move. [Apply for this job](#job-application)[View company](https://jobicy.com/company/precision-medicine-group.md)ShareRemote from[Japan](https://jobicy.com/job-region/japan.md)SalaryUndisclosedDepartment[Healthcare & Medical](https://jobicy.com/categories/healthcare.md)EmploymentFull TimeExperienceSeniorPublished19 Oct 2026Apply before18 Nov 2026Listing views40Application actions2Application toolkit ## Make your next move. Prepare your resume, explore your fit, and draft a cover letter for this opportunity. AI Summary ## The role, at a glance. This is a remote clinical pharmacovigilance role supporting safety operations for clinical trials, with eligibility indicated for Japan. The Safety Specialist/Safety Lead manages SAE and SUSAR cases from intake through regulatory reporting, including coding, expectedness assessment, narratives, and quality control. The position also develops safety plans, reporting processes, training materials, SOPs, and supports sponsors, vendors, clients, and study teams. Candidates need at least five years of safety experience, healthcare-professional credentials, and practical knowledge of global safety databases, MedDRA, WHODrug, FDA, ICH, and global regulations. Experience with Argus and CRO or pharmaceutical environments is preferred. ## Role DNA A quick view of the complexity, pace, ownership and collaboration implied by the job description. ### Job Complexity 4/5EasyHard ### Pace & Pressure 4/5RelaxedFast-paced ### Autonomy Level 4/5GuidedFull ownership ### Communication Load 4/5IndependentCollaborative AI insightThe role requires detailed command of global pharmacovigilance requirements and end-to-end processing of serious safety cases where accuracy and reporting timelines are critical. It also combines individual case work with client-facing consultation, training, quality review, and process development. ## Salary analysis Estimated compensation compared with the broader US market for similar roles. Estimated job median (per year)Market rate$80,000US market range (per year)$65k–$100k0$110.00k AI insightThe yearly pay period is inferred from the job context; it was not explicitly stated by the employer. No employer compensation was disclosed. Estimated annual market compensation is shown in USD for a mid-to-senior clinical safety specialist/lead; the selected annual cadence is inferred from the regular full-time professional role. ## Core skills Skills and capabilities most closely associated with this opportunity. [Pharmacovigilance](https://jobicy.com/jobs?search_keywords=Pharmacovigilance.md)[SAE case processing](https://jobicy.com/jobs?search_keywords=SAE%20case%20processing.md)[SUSAR reporting](https://jobicy.com/jobs?search_keywords=SUSAR%20reporting.md)[ICSR management](https://jobicy.com/jobs?search_keywords=ICSR%20management.md)[Safety narrative writing](https://jobicy.com/jobs?search_keywords=Safety%20narrative%20writing.md)[MedDRA coding](https://jobicy.com/jobs?search_keywords=MedDRA%20coding.md)[WHODrug coding](https://jobicy.com/jobs?search_keywords=WHODrug%20coding.md)[Safety database management](https://jobicy.com/jobs?search_keywords=Safety%20database%20management.md)[Argus Safety](https://jobicy.com/jobs?search_keywords=Argus%20Safety.md)[FDA safety regulations](https://jobicy.com/jobs?search_keywords=FDA%20safety%20regulations.md)[ICH guidelines](https://jobicy.com/jobs?search_keywords=ICH%20guidelines.md)[Global safety reporting](https://jobicy.com/jobs?search_keywords=Global%20safety%20reporting.md)[Quality control](https://jobicy.com/jobs?search_keywords=Quality%20control.md)[Clinical trial safety](https://jobicy.com/jobs?search_keywords=Clinical%20trial%20safety.md)[Safety management plans](https://jobicy.com/jobs?search_keywords=Safety%20management%20plans.md) Sample interview questionsHow do you manage an SAE case from initial intake through regulatory reporting?I first confirm receipt and assess case validity, seriousness, expectedness, and reportability. I enter and code the case in the safety database, conduct follow-up as needed, prepare a medically coherent narrative, complete quality checks, and ensure submissions meet applicable local and global reporting timelines. What steps do you take to ensure the quality of an individual case safety report? I use a structured QC process that verifies source consistency, patient and event details, MedDRA and drug coding, dates, seriousness criteria, expectedness, narrative accuracy, and submission status. I also document discrepancies and ensure corrections are traceable and completed before finalization. How have you used MedDRA and WHODrug in pharmacovigilance work? I use MedDRA to code adverse events and medical history at the most appropriate level of specificity, and WHODrug to standardize medicinal product coding. I validate coding against source information and follow the study-specific coding convention and internal procedures. How would you respond to a sponsor asking for urgent safety data analysis during an ongoing study? I would clarify the question, timeline, data cut, and intended use, then coordinate with the relevant safety and data-management stakeholders. I would provide a quality-reviewed analysis based on current case data, clearly state limitations, and communicate findings in a timely, documented manner. Describe how you would train a new team member or contractor on safety case processing. I would begin with applicable SOPs, reporting plans, system workflows, and regulatory timelines, then demonstrate representative cases and supervise practice cases. I would use targeted feedback, document training completion, and confirm competency through reviewed work before independent processing. Opportunity details ## About this role. Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. As our company continues we grow we are seeking a Safety Specialist/Safety Lead to join our growing team. 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. Requirement: • 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 Any data provided as a part of this application will be stored in accordance with our [Privacy Policy.](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&reserved=0) For CA applicants, please also refer to our [CA Privacy Notice](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&reserved=0). 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](mailto:myHR@precisionmedicinegrp.com). Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [myHR@precisionmedicinegrp.com](mailto:myHR@precisionmedicinegrp.com) so we can investigate and take appropriate action. Candidates must be legally authorized to work in the country of employment without employer sponsorship. Show more [Apply now >](https://jobicy.com/jobs/155910-safety-specialist-safety-lead.md) > Annual salary information is not provided for this position. 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