Global Product Monitoring Vigilance Report Writer

Job Summary Are you an experienced Medical Device Vigilance or Pharmacovigilance professional looking to broaden your international exposure?

The Global Product Monitoring Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices which meet customer, regulatory, and client requirements; serves as a post-market vigilance (reportable event) and surveillance subject matter expert and representative to improve awareness, visibility, and communication on quality/compliance initiatives to support departmental, divisional, and corporate quality goals and priorities;

works on problems of diverse scope where analysis of data requires evaluation of identifiable factors; demonstrates good judgment in selecting methods and techniques for obtaining solutions; and networks with senior internal and/or external personnel in own area of expertise.  Responsibilities:  •  Responsible for the assessment, follow-up, coding, and vigilance activities for complaints globally.  •  Author, peer review, and approve vigilance reports to ensure on time submissions to the appropriate regulatory authorities. 

•  Support management in day-to-day operations in a fast-paced work environment;
Support proper coding of complaints and reportable events.  •  Collaborate with engineering, complaint investigation laboratory, medical and other internal staff as applicable to review events, coding, and investigation results to support regulatory reporting compliance occurs per procedures, standards, and regulations.  •  Support training, mentorship, and/or review of post-market team members. •  Serve as a subject matter expert for post-market and complaint handling regulatory questions and inquiries. 

•  Support internal and external audits and inspections, as applicable.  •  Assist with special projects, as assigned, with minimal supervision.  •  Perform other duties as required. 

Minimum Requirements:

  •  Bachelor’s degree or appropriate combination of relevant education and experience.   •  Demonstrated experience in medical device complaint triage and vigilance reporting or clinical experience in diabetes disease management or diabetes device support. Preferred Skills and

Competencies:

  •  Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook) and complaint database applications.  •  Effective verbal and written communication skills.  •  Ability to generate, verify, and maintain accurate records.  •  Must have analytical skills, be detail oriented, and have good interpersonal skills.  •  Demonstrated ability to influence without authority.  •  Ability to organize, judge priorities, and escalate when applicable.  •  Strong emphasis and understanding of a formalized medical device Quality Management System. 

•  Direct experience of writing and filing global vigilance reports within the medical device industry.  •  Working knowledge/experience with global, multi-country vigilance reporting requirements for medical devices and demonstrated knowledge of country-specific differences and requirements.  •  Experience in dealing directly with regulatory bodies and Prestataires are highly desired.•  BSN with diabetes experience, Registered or Licensed Dietitian or Diabetic Educator, preferred.  Travel and

Physical Requirements:

•  General office environment – may sit for long periods of time.  •  This position requires extensive computer use.  •  May require up to 10% travel Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod…