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Medical Safety Specialist

Date:  Nov 24, 2020
Location: 

Danvers, MA, US

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,500 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

 

Patients First | Innovation | Winning Culture | Heart Recovery
 

 

The Medical Safety Specialist reports into Medical Safety Department (part of the Medical Office) and is responsible for implementing and executing the safety functions and responsibilities for the medical and clinical research programs.

Job Responsibilities:

  • Go-to person in clinical trial safety (designated trials): includes creation, maintenance and execution of safety management plan, managing safety contracts (CEC, DSMB, monitors, etc) and committee meetings. Ensure timely and accurate execution of safety processes such as initial medical review of events,  reconciliation between EDC & safety database, issue/follow up on source queries, track to pre-specified study timelines, aggregate/periodic reporting, process improvements, and other clinical trial safety activities.
  • Supports the design, authoring, implementation, and execution of standard operating procedures (SOPs)
  • Conduct medical reviews of events reported in clinical trials, post-market databases, and other sources.
  • Participate on cross-functional teams involved in the development or support of products including research and development, quality engineering, medical affairs, clinical research, regulatory affairs and quality assurance.
  • Comply with guidelines, standards and regulations pertaining to medical information provided to customers.
  • Partner with the Head of Global Safety to escalate detected signals and patterns to leadership with recommended next steps.
  • Prepare safety response letters and medical to medical communications together with Medical Affairs clinicians and the Medical Safety Officer.
  • Perform medical record assessment

Job Qualifications:

  • Bachelor’s Degree in Nursing or life sciences required; Advanced degree preferred
  • Minimum 5 year of experience in medical device medical safety, complaint handling, quality & regulatory systems, or related
  • Experience leading and influencing in a matrix environment
  • Effective analytical and problem-solving skills; Ability to work with a minimal amount of supervision; Well-developed written and communication skills
  • Experience with international clinical studies preferred 
  • Ability to coordinate and lead multiple projects simultaneously
  • Exceptional interpersonal skills and willingness to work in a team environment
  • Knowledge and proficient use of Microsoft Office Suite Applications (Word, Excel, Power Point, and Microsoft Project)

 

 

Miscellaneous:

This is a field-based position: In the initial period (first 90 days). The following activities will be planned during the initial period:

  • Onboarding
  • Establish necessary rapports and fully immerse with peers, cross-functional teams, and support staff
  • Complete adoption of the Abiomed strategy: Attend company meetings (especially core-team, company meetings)
  • Work closely with Head of Medical Safety on goals, expectations, and deliverables
  • Reach a company and department representation level.

 

 

 

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.


Nearest Major Market: Boston