Precision For Medicine · 3 days ago
Safety Specialist II
Remote, United States
Full-time
Remote
Mid Level
$72K/yr - $109K/yr
3+ years exp
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Responsibilities
Interfacing with sponsors, vendors, and other internal team members related to drug 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.
Preparation and/or review of project‑specific safety reporting plans and medical coding plans.
Preparation and/or review of safety training materials.
Review and/or draft standard operating procedures and work instructions.
Mentor or train new PV staff
May participate (support, review, draft, provide input, etc.) in strategic department development initiatives.
Perform other duties as assigned.
Qualification
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Required
4-year college degree, or equivalent experience ideally in Pharmacy, Nursing, scientific or healthcare discipline
3-5 years clinical trial, PV/Drug Safety experience
Working knowledge of GCP/ICH guidelines and the clinical development process
Health care professional (i.e., RN, BSN, MD, PharmD)
Hands on experience with global safety database(s), SAE case processing including narrative writing, and safety reports generation
Proficient MedDRA and WHO Drug coding
Applies advanced knowledge of the organization, process and structure of clinical studies, PV systems and processes
Ability to oversee, manage, and resolve higher level, complex problems and prioritize workload to meet timelines with some support from management
Good understanding of technical and content knowledge
Anticipates case processing needs, identifies, and communicates timelines
Responsible for case processing on a broad range of clinical studies under the minimal direction of a Safety Lead or other Safety Management
Advanced knowledge and understanding of Global safety regulations, MedDRA, WHO Drug, and GCP and ICH guidelines
Applies more in-depth knowledge of Argus Safety Database
Organizes work and priorities effectively with minimal oversight; understand hierarchy of responsibilities
Manages timelines, communicate flow and deliverables, and monitor progress
Solid knowledge and understanding of FDA safety regulations, EMA, MedDRA, WHO Drug, MHRA and other ICH guidelines, and global safety regulations
Solid understanding of clinical trials methodology
Ability to work collaboratively with others but exhibits self-motivation and able to work independently
May resolve Safety related issues and prioritize workload to meet timelines with minimal support from management
May work on multiple complex clinical studies and Safety activities
Preferred
Oncology and Rare Disease experience
Industry experience in CRO and/or pharmaceutical company preferred
Benefits
Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation
Company
Precision For Medicine
Precision for Medicine is a specialized scientific services company helping life science innovators develop medical products. It is a sub-organization of Precision Medicine Group.
1,001-5,000 employees
H1B Sponsorship
Precision For Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (15)
2022 (8)
2021 (12)
2020 (11)
Funding
Current Stage
Late StageTotal Funding
$225M2015-12-22Private Equity· $75M
2013-04-02Private Equity· $150M
Leadership Team
Jared Kohler
Sr. Vice President, Project Management & Data Science Operations & Precision for Medicine
Jay Lezcano
SVP & Business Development
Recent News
2024-10-30
2024-06-03
Company data provided by crunchbase
