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Assoc Clinical Safety Specialist

Saint Paul, MN 55112

Posted: 02/09/2024 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 599651 Is job remote?: Yes Country: United States

Job Description


The Clinical Safety Specialist is responsible for safety and potential complaint data throughout the clinical study to ensure compliance with respect to the reporting of clinical study safety and potential complaint data to meet regulatory requirements. The MCRS Clinical Safety Specialist will partner with various colleagues across the company (e.g., other members of the MCRS Clinical Safety team, other MCRS functions, Regulatory Affairs, Clinical teams in the Operating Units) to manage adverse event, death, and device deficiency reporting in compliance with applicable regulatory standards and internal requirements.

 

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. This company walks the walk, creating an inclusive culture where you can thrive.  Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within the company and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute.  We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communications if we hope to have long-term sustainable impact.

 

Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of our employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.

 

Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to be a part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career.  We encourage and support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.  Join us for a career that changes lives.  This company is committed to fostering a diverse and inclusive culture. 
 

A DAY IN THE LIFE
  • Review and assess clinical study Adverse Events (AEs) including Serious Adverse Events (SAEs) and device deficiencies
  • Review non-AE Case Report Forms to detect potential complaint and potential unreported AEs
  • Interact with investigational sites and clinical monitors to obtain additional pertinent information as indicated in the Clinical Investigation Plan (CIP)
  • Ensure consistency in the assessment of clinical safety events
  • Work with Regulatory Affairs and the Product Complaint Reporting teams to ensure timely reporting of AEs, SAEs, and Unanticipated Serious Adverse Device Effects (U[S]ADEs) and potential complaints
  • Ensure appropriate distribution and notification of SAEs and U[S]ADEs to appropriate personnel, partners, and investigational sites per CIP
  • Act as liaison for safety-related questions (e.g., to study team, field support, monitors, and study sites)
  • Author Clinical Safety Management and Potential Complaint Plan (CSMPCP) for assigned studies
  • Assist with preparation of assigned section of safety reports for annual reports, clinical study reports, and other documents as required
  • Collaborate with Data Management and other departments on the development of case report forms, study specific safety reports, and other study specific forms
  • Assist with the writing of safety sections of CIPs and may present Clinical Safety requirements at investigator meetings
  • Support study audit for Safety-specific topics
  • Facilitate Clinical Event Committee (CEC) work (author CEC charter, review source documents, ensure all CEC events are adjudicated by CEC)
  • Support database snapshot activities (e.g., meet with study team, review timelines, perform reconciliation and data cleaning activities to be audit & snapshot ready)
  • Prepare, attend and/or lead Safety Trending meetings
  • Perform other Clinical Safety tasks as assigned

 

BASIC QUALIFICATIONS

 

MUST HAVE (Minimum Qualifications)
  • Bachelor’s degree
  • 2+ years of experience with a bachelor’s degree or 0+ years of experience with an advanced degree

 

DESIRED/PREFERRED QUALIFICATIONS

NICE TO HAVE (Preferred Qualifications)
  • Technical degree (BS) preferred
  • Safety Experience
  • Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
  • Good written, oral, and interpersonal communication skills including knowledge of medical terminology
  • Proficient with MS Office products, word processing, spreadsheets, etc.
  • High attention to detail and accuracy and ability to manage multiple tasks
  • Good prioritization and organizational skills
  • Excellent problem-solving skills
  • Flexible and dependable
  • Works effectively on cross-functional teams

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Saint Paul, MN

Explore exciting job opportunities in the vibrant area around Saint Paul, Minnesota! Known as the 'Twin Cities' area along with Minneapolis, Saint Paul offers a dynamic job market with ample room for growth and development. Considered the state capital, Saint Paul boasts a unique blend of historic charm and modern amenities. From the iconic Cathedral of Saint Paul to the bustling Saint Paul Farmers Market, there is always something to discover in this culturally rich city. With renowned art galleries like the Minnesota Museum of American Art, world-class theaters such as the historic Fitzgerald Theater, and beloved sports teams like the Minnesota Wild hockey team calling the Xcel Energy Center home, there's no shortage of entertainment options. Embrace the Midwest's warm hospitality and endless outdoor activities in beautiful parks like Como Park and the Mississippi River trails. Let's kickstart your career in this thriving and enchanting region – browse our job listings today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.