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Senior Clinical Safety Specialist

Employer
RefleXion
Location
Hayward, CA
Start date
Dec 23, 2021

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Discipline
Administration, Clinical, Clinical Medicine
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details


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

 

 

Company

RefleXion is a privately held therapeutic oncology company located in Hayward, Calif., transforming radiopharmaceuticals from diagnosing cancer to actively controlling delivery of external-beam radiotherapy by leveraging individual tumor biology. Designated an FDA Breakthrough Device, RefleXion’s SCINTIX™ biology-guided radiotherapy automates targeting and motion management to overcome long-standing barriers preventing definitive radiotherapy for metastatic disease. In strategic collaborations with radiopharmaceutical companies, RefleXion is co-developing and co-commercializing disease-specific radiopharmaceuticals for difficult to treat late-stage cancers. RefleXion’s vision is to extend the established safety, efficacy and cost-effectiveness of external-beam radiotherapy to patients with solid tumor malignancies of any stage.

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Company info
Website
Location
25841 Industrial Blvd
#275
Hayward
California
94545
US

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