Description

The Senior Clinical Safety Specialist will provide medical and process-related safety expertise for RefleXion Medical clinical studies and safety monitoring activities, ensuring safety data review and evaluation in accordance with relevant pre-market and post-market regulatory requirements and Standard Operating Procedures (SOPs).

The Senior Clinical Safety Specialist will be the subject matter expert for maintaining in-depth therapeutic and product knowledge, and knowledge regarding clinical studies and product safety including risk assessments, post-market surveillance and health hazard evaluations.

Responsibilities

  • Providing safety expertise and oversight for clinical studies
  • Providing safety input and review of clinical study documents including study protocols, case report forms, training materials, other clinical and regulatory documents, as appropriate
  • Developing and/or maintaining study-specific safety processes and templates.
  • Comprehensive safety review and documentation of adverse events and product experiences reported in clinical studies
  • Data entry of case reports into safety database or tracking system
  • Safety query management and follow-up
  • Coding of medical data
  • Writing case narratives
  • Managing safety related clinical study activities, including Data Monitoring Committees
  • Supporting preparation of clinical study reports, periodic safety reports for submission to regulatory agencies and IRBs/IECs, and other ad hoc reports and documents, as needed
  • Collaborating and providing subject matter expertise and consultation to internal and external stakeholders, including Regulatory Affairs and Quality Assurance departments, as needed.
  • Other duties as assigned

Requirements

  • Bachelor’s degree or equivalent in health care field (RN, BSN, MBBS, DPharm) is required.
  • MD, NP, PhD in Biological or Life Sciences, or Master’s in Public Health is strongly preferred
  • A minimum of 8 years of clinical research experience with 5+ years as a Safety Specialist/Medical Monitor, preferably 3+ years in medical devices studies.
  • Radiation oncology and/or oncology experience required.
  • Experience monitoring medical device studies required.
  • Proficient in medical terminology and MedDRA
  • Excellent knowledge of FDA and ICH regulations, guidelines, and reporting requirements for adverse events and medical device complaints
  • Demonstrated knowledge of device development principles, clinical study methodology, medical monitoring of clinical studies, assessment of drug/device risks and benefits, and safety assessment of medical devices
  • Experience using electronic databases for clinical study and safety management
  • Drug Safety (Pharmacovigilance) Case Processing experience preferred.
  • Ability to manage multiple projects and priorities, with strong attention to detail
  • Strong verbal and written communication skills

Company Benefits and Perks – What you will love about us!

All positions at RefleXion are eligible to receive the same benefits, listed here. We also want to highlight the following perks that add to our collaborative and team-work company culture.  As we continue to grow as a company, we strive to have these benefits and perks grow with us – we are so excited for what is in store! 

  • The opportunity to work with a passionate, driven team in a pre-IPO start-up environment
  • Competitive compensation and stock option package
  • Three (3) weeks PTO to start
  • Medical (both HMO and PPO options), Dental and Vision
  • Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Flexible Spending Account (DCFSA)
  • Employee Assistance Program (EAP)
  • 401K
  • Employer paid Life Insurance
  • RefleXion Benefit Hub – for company exclusive discounts and deals on a variety of sites and items
  • Daily on-site lunches
  • Kitchens filled with a variety of healthy and delicious snacks and drinks – including espresso and soda machines!
  • Company culture building events such as Coffee Chats with the Executives, Friday Afternoon Ice Cream Socials and monthly Book Club
  • On-site mobile car wash services weekly
  • Electric car charging stations on site

 

 

Apply for this Job

* Required

  
  


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at RefleXion Medical are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

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.

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 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.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, 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?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

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.