Job Application for Safety Specialist II at Precision Medicine Group

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won’t you join us today as a Safety Specialist II?

Position Summary:

Responsibilities will include but may not be limited to; for the intake and triage, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) reports according to applicable regulatory guidelines/requirements, Precision for Medicine (PFM) Standard Operating Procedures (SOPs) and project specific instructions.

Independently serves as primary safety specialist on complex studies, applying and providing guidance and safety expertise to clients and team members on Pharmacovigilance best practices tailored to the applicable project, patient population, investigational product and client.

Essential functions of the job include but are not limited to:

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.

Qualifications:

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.

Minimum 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

Other Required:

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
Solves complex problems using knowledge/skills, precedents and practices.
Exercises independent judgment within broadly defined practices in selecting approaches and methods for obtaining results.
Seeks support for some challenges and problems and proposed solutions
Recognizes appropriate issues for escalation.
Able to apply advanced Safety Database troubleshooting skills and abilities.
Demonstrates good judgment in selecting approaches, processes, and techniques for obtaining solutions.
Strong knowledge of FDA safety regulations, ICH guidelines, and global safety regulations.

Preferred:

Oncology and Rare Disease experience
Industry experience in CRO and/or pharmaceutical company preferred.

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$72,500 - $108,700 USD

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

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. © 2020 Precision Medicine Group, LLC

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 QuestionForHR@precisionmedicinegrp.com.

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

First Name

Last Name

Phone

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

School

Select...

Degree

Select...

Discipline

Select...

Start date year

LinkedIn Profile

What is your desired salary?

Are you authorized to work lawfully in the country/location for which you are applying?

Select...

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.

Select...

Have you ever worked for Precision Medicine Group or one of its affiliated companies?

Select...

If yes, when and which company?

Have you ever interviewed with Precision Medicine Group or an affiliated company?

Select...

If yes, when and which company?

Are you currently subject to a Non-Compete or Non-Solicit with your current employer?

Select...

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 resumes as it relates to the position I am seeking and to the extent permitted by federal, state, or local law. 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 federal, state, and local law, 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 United States. I also understand that the Company employs only individuals who are legally eligible to work in the United States. This application will remain active for 60 days. Any applicant wishing to be considered for employment after that time must reapply. UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.

Select...

Legal Address - Street Address 1

Legal Address - Street Address 2

Legal Address - City

Legal Address - State

Select...

Legal Address - Zip

Legal Address - Country

Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Precision Medicine Group’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Gender

Select...

Are you Hispanic/Latino?

Select...

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran Status

Select...

Voluntary Self-Identification of Disability

Form CC-305

Page 1 of 1

OMB Control Number 1250-0005

Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury

Disability Status

Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Safety Specialist II

Apply for this job

Voluntary Self-Identification

Voluntary Self-Identification of Disability