Pharmacovigilance Scientist - CRO - Remote US

Work from Home

Lebanon Tennessee

United States

Scientific Research
(No Timezone Provided)

Description

Introduction

Do you have the career opportunities as a(an) Principal Safety Lead - CRO - Remote US you want with your current employer? We have an exciting opportunity for you to join Work from Home which is part of the nation's leading provider of healthcare services, HCA Healthcare.

Benefits

We are committed to providing our employees with the support they need. At Sarah Cannon, we offer eligible colleagues an attractive benefit package that includes medical, wellbeing, dental and vision benefits along with additional unique benefits including:

  • Medical, Dental, Vision, Life Insurance and Flexible Spending
  • Paid Time Off (PTO) and Personal Leave
  • 401K (100% annual match - 3% to 9% of pay based on years of service)
  • Academic Assistance and Reimbursements for Tuition and Student Loans
  • Employee Discounts including Tickets, Retail, Mental Health Apps, Education Apps, Identity Theft Protection etc.
  • Home, Auto, and Pet Insurance
  • Employee Stock Purchase Program (ESPP)
  • Short Term & Long Term Disability coverage
  • Adoption Assistance
  • Legal Benefits and lots more!

Learn more about Employee Benefits

Our teams are a committed, caring group of colleagues. Do you want to work as a Principal Safety Lead where your passion for creating positive patient interactions are valued? If you are dedicated to caring for the well-being of others, this could be your next opportunity. We want your knowledge and expertise!

Job Summary 

Our Principal Safety Lead authors or inputs to safety related documents (annual safety reports, safety signal reviews, safety query responses, patient informed consent risks section, safety section of Investigator’s Brochure, safety section of clinical study report etc.) Additionally, this position leads program level safety oversight activities for development compounds including: Safety surveillance, Literature review, Determination of adverse drug reactions, Assessment of potential and identified risks, Safety signal tracking/management, leading regular and ad hoc safety meetings, and Preparing program safety governance charter.

Duties include and are not limited to

  • Facilitate ongoing safety surveillance for assigned products
  • Demonstrate the ability to lead safety surveillance teams for multiple products
  • Provide support to the PV physicians in development of the safety profile
  • Conducts literature searches/reviews on a defined basis for developmental products
  • Manage delivery of aggregate safety reports such as DSURs and period SUSAR Line Listings
  • Support the preparation, maintenance and review of safety sections (including but not limited to clinical study protocols, ICFs, Investigator Brochures, and clinical study reports)
  • Provide input or feedback for processes and templates associated with pharmacovigilance and reporting
  • Participate in meetings, representing the PV and Safety department
  • Assist in monitoring industry best practices, and changes in global safety regulations and guidelines for marketed and investigational products, and recommend changes and upgrades to existing departmental policies, SOPs and systems
  • Maintain a high level of understanding of federal and international regulations and guidance in order to guide departmental policies and procedures

Qualifications Needed

  • Bachelor’s Degree (4-year program) required, Master’s Degree preferred
  • 7+ years’ experience with clinical trials, study design, ICH/GCP knowledge and training; knowledge of safety and clinical electronic data management systems (ARGUS or equivalent); experience with global PV regulations (FDA, EMA, MGRA) required; medical, scientific, and clinical research terminology required. 

Sarah Cannon is the Cancer Instituteof HCA Healthcare. We offerintegrated cancer services with easy access to cutting-edge therapies for communitiesacross the United States and United Kingdom. Sarah Cannon’s cancer programs include individualized patient navigation. Ournurses are oncology-trained. Morethan 1,200 stem cell transplants are performed yearly within the Sarah Cannon Blood Cancer Network.Through its services, Sarah Cannonprovides state-of-the-art cancer care for hundreds of thousands of patients. Ourcancer experts are collaborating and sharing best practices. We address every aspect of the cancer journey, from screening anddiagnosis through treatment and survivorship.

HCA Healthcare has been named one of the World's Most Ethical Companies by Ethisphere Institutefor over a decade.  In recent years, HCA Healthcare spent an estimated $3.7 billion in cost for thedelivery of charitable care, uninsured discounts, and other uncompensated expenses.


"Bricks and mortar do not make a hospital. People do."- Dr. Thomas Frist, Sr.
HCA Healthcare Co-Founder

If you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our Principal Safety Lead - CRO - Remote US opening. We promptly review all applications. Highly qualified candidates will be contacted for interviews. Unlock the possibilities and apply today!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Pharmacovigilance Scientist - CRO - Remote US

Work from Home

Lebanon Tennessee

United States

Scientific Research

(No Timezone Provided)

Description

Introduction

Do you have the career opportunities as a(an) Principal Safety Lead - CRO - Remote US you want with your current employer? We have an exciting opportunity for you to join Work from Home which is part of the nation's leading provider of healthcare services, HCA Healthcare.

Benefits

We are committed to providing our employees with the support they need. At Sarah Cannon, we offer eligible colleagues an attractive benefit package that includes medical, wellbeing, dental and vision benefits along with additional unique benefits including:

  • Medical, Dental, Vision, Life Insurance and Flexible Spending
  • Paid Time Off (PTO) and Personal Leave
  • 401K (100% annual match - 3% to 9% of pay based on years of service)
  • Academic Assistance and Reimbursements for Tuition and Student Loans
  • Employee Discounts including Tickets, Retail, Mental Health Apps, Education Apps, Identity Theft Protection etc.
  • Home, Auto, and Pet Insurance
  • Employee Stock Purchase Program (ESPP)
  • Short Term & Long Term Disability coverage
  • Adoption Assistance
  • Legal Benefits and lots more!

Learn more about Employee Benefits

Our teams are a committed, caring group of colleagues. Do you want to work as a Principal Safety Lead where your passion for creating positive patient interactions are valued? If you are dedicated to caring for the well-being of others, this could be your next opportunity. We want your knowledge and expertise!

Job Summary 

Our Principal Safety Lead authors or inputs to safety related documents (annual safety reports, safety signal reviews, safety query responses, patient informed consent risks section, safety section of Investigator’s Brochure, safety section of clinical study report etc.) Additionally, this position leads program level safety oversight activities for development compounds including: Safety surveillance, Literature review, Determination of adverse drug reactions, Assessment of potential and identified risks, Safety signal tracking/management, leading regular and ad hoc safety meetings, and Preparing program safety governance charter.

Duties include and are not limited to

  • Facilitate ongoing safety surveillance for assigned products
  • Demonstrate the ability to lead safety surveillance teams for multiple products
  • Provide support to the PV physicians in development of the safety profile
  • Conducts literature searches/reviews on a defined basis for developmental products
  • Manage delivery of aggregate safety reports such as DSURs and period SUSAR Line Listings
  • Support the preparation, maintenance and review of safety sections (including but not limited to clinical study protocols, ICFs, Investigator Brochures, and clinical study reports)
  • Provide input or feedback for processes and templates associated with pharmacovigilance and reporting
  • Participate in meetings, representing the PV and Safety department
  • Assist in monitoring industry best practices, and changes in global safety regulations and guidelines for marketed and investigational products, and recommend changes and upgrades to existing departmental policies, SOPs and systems
  • Maintain a high level of understanding of federal and international regulations and guidance in order to guide departmental policies and procedures

Qualifications Needed

  • Bachelor’s Degree (4-year program) required, Master’s Degree preferred
  • 7+ years’ experience with clinical trials, study design, ICH/GCP knowledge and training; knowledge of safety and clinical electronic data management systems (ARGUS or equivalent); experience with global PV regulations (FDA, EMA, MGRA) required; medical, scientific, and clinical research terminology required. 

Sarah Cannon is the Cancer Instituteof HCA Healthcare. We offerintegrated cancer services with easy access to cutting-edge therapies for communitiesacross the United States and United Kingdom. Sarah Cannon’s cancer programs include individualized patient navigation. Ournurses are oncology-trained. Morethan 1,200 stem cell transplants are performed yearly within the Sarah Cannon Blood Cancer Network.Through its services, Sarah Cannonprovides state-of-the-art cancer care for hundreds of thousands of patients. Ourcancer experts are collaborating and sharing best practices. We address every aspect of the cancer journey, from screening anddiagnosis through treatment and survivorship.

HCA Healthcare has been named one of the World's Most Ethical Companies by Ethisphere Institutefor over a decade.  In recent years, HCA Healthcare spent an estimated $3.7 billion in cost for thedelivery of charitable care, uninsured discounts, and other uncompensated expenses.


"Bricks and mortar do not make a hospital. People do."- Dr. Thomas Frist, Sr.
HCA Healthcare Co-Founder

If you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our Principal Safety Lead - CRO - Remote US opening. We promptly review all applications. Highly qualified candidates will be contacted for interviews. Unlock the possibilities and apply today!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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