Safety Specialist/Safety Lead
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
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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.
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Skills
As published by greenhouse · 16 questions
Basics
First Name, Last Name, Email, Phone, Resume/CV, Cover Letter, Location
Short answers (8)
- LinkedIn Profile optional
- What is your desired salary?
- If yes, when and which company? optional
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- Legal Address - Street Address 1
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Pick from a list (8)
- Are you authorized to work lawfully in the country/location for which you are applying?
- Will you now or in the future require Precision Medicine Group to commence (sponsor) an immigration case in order to employ you (for example, work visa application or work visa transfer, or other-employment based immigration case)? This is sometimes called "sponsorship" for an employment-based visa status.
- Have you ever worked for Precision Medicine Group or one of its affiliated companies?
- Have you ever interviewed with Precision Medicine Group or an affiliated company?
- Are you currently subject to a Non-Compete or Non-Solicit with your current employer?
- I certify that the information on this application, my resume and any supporting documentation I provide is complete and accurate to the best of my knowledge. If this application leads to employment, I understand that false or misleading information in my application, resume or interview may result in my release or termination of employment. I authorize the Company or its agents to confirm all statements contained in this application and/or curriculum vitae as it relates to the position I am seeking and to the extent permitted by the laws of the country where the job is located (“Applicable Laws”). I agree to complete any required authorization forms for the background investigation. I authorize and consent to, without reservation, any party or agency contracted by this employer to furnish the above-mentioned information. I hereby release, discharge, and hold harmless, to the extent permitted by Applicable Laws, any party delivering information to the Company or its duly authorized representative pursuant to this authorization from any liability, claims, charges or causes of action which I may have as a result of the delivery or disclosure of the above requested information and all other persons, corporations, or organizations furnishing such information. If hired, I understand that I will be required to provide genuine documentation establishing my identity and eligibility to be legally employed in the country where the job is located. I also understand that the Company employs only individuals who are legally eligible to work in the country where the job is located.
- Legal Address - State
- Legal Address - Country