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Medical Safety Associate Director

at Novocure

Posted: 6/25/2019
Job Status: Full Time
Job Reference #: 1106509
Keywords:

Job Description

  • Medical Affairs
  • Portsmouth, NH, USA
  • Salary
  • Full Time

The Medical Safety Associate Director is a new position responsible for the implementation of practices, policies, and processes for the Medical Safety Group to ensure the provision of safety vigilance and mandatory safety reporting throughout the medical device product lifecycle.  Reporting to the Senior Director, Global Medical Safety, this is a full-time exempt position located in our Portsmouth, NH office.

 

Essential Duties and Responsibilities:

  • Manage the US Medical Safety team
  • Generate and implement new ideas, concepts and processes to continuously improve Medical Safety and maintain compliance with global regulations
  • Assist with product lifecycle risk management activities and documentation
  • Participate in FDA, Notified Body and internal audits as a Subject Matter Expert for Medical Safety
  • Ensure continuous cross-functional collaboration to meet business objectives
  • Ensure global harmonization of processes among Medical Safety teams
  • Ensure product safety issues are quickly identified, understood from a patient risk standpoint, and escalated appropriately to ensure proper action is taken
  • Assist with the integration, analysis and interpretation of safety information from all sources (clinical through post-approval lifecycle management and externally)
  • Acts as the lead within the Medical Safety department for all duties and Corrective & Preventative Actions (CAPA)-related responsibilities as needed
  • Assist with signal detection and signal management activities
  • Assist with providing evidence-based medical safety input, education and/or response to safety inquiries from internal or external stakeholders (e.g., external medical personnel or other third-parties, including regulatory agencies or health care organizations)
  • Exercise judgment in planning, organizing, performing, coordinating and/or directing work
  • Foster an innovative culture, ensuring a collaborative, high performing Medical Safety team
  • Recognize and direct organizational and individual contributor development needs and opportunities for continuous improvement within Medical Safety

 

Required Skills & Competencies:

  • Knowledge of FDA and international medical device reporting (MDR) regulations per guidelines and the ability to interpret and apply applicable regulations
  • Ability to understand and evaluate technical, scientific and medical information
  • Ability to analyze case and query data and communicate results and propose recommendations
  • Understanding of medical terminology and MedDRA coding
  • Ability to work independently with little supervision; self-motivation is a must
  • Excellent problem solving skills
  • Excellent project management skills
  • Excellent written, oral, and presentation communication skills
  • Ability to manage ongoing multiple tasks, be responsive to critical situations and changing priorities
  • Strong interpersonal skills with the ability to lead teams
  • Ability to manage conflict
  • Demonstrated proficiency in staff leadership and development
  • Ability to work in a dynamic, global, multicultural environment

 

Qualifications:

 

               Required Qualifications:

 

  • Bachelor's Degree required, preferably in biology, nursing, pharmacy or other health related profession; RN or PharmD degree strongly preferred
  • 5+ years' experience in medical device company and/or minimum 5+ years' experience in a healthcare setting with exposure to the regulated portion of the healthcare industry desired
  • 5+ years' experience in medical device safety/drug safety/pharmacovigilance-related experience in medical device/pharmaceutical/biotechnology industry
  • Experience in a FDA regulated environment
  • Knowledge of U.S. Food and Drug Administration (FDA) regulations for medical device companies, including medical device reporting
  • Knowledge based PC computer skills essential, such as industry recognized complaint management systems, MS Project, Excel and PowerPoint

 

               Preferred Qualifications:

 

  • Advanced degree in biological science, nursing, pharmacy or other healthcare related profession
  • 5+ years of medical device safety experience
  • 5+ years of management experience preferred
  • 5+ years of experience in the medical device industry, especially in complaint handling, post market surveillance and regulatory affairs
  • Oncology experience
  • Project Management experience

 

Working Conditions / Misc.:

 

  • Open office environment
  • Minimal domestic and international travel

 

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