Senior Principal Medical Safety Specialist

Job Description

As a Senior Principal Medical Safety Specialist (Sr.Pr. MSS) you will have an integral role in the day-to-day functioning of the global medical safety organization. In this vital role you will facilitate, develop, and execute upon medical safety processes globally at Olympus. As an individual contributor you will lead and influence the science and practice of all medical safety activities related to the detection, assessment, understanding of product risks and their effective mitigations to protect patients worldwide. You will demonstrate the advanced ability to apply your clinical experience, product expertise, and medical safety domain knowledge to lead, collaborate, and influence patient safety in activities being performed cross-functionally across the product lifecycle for all Olympus therapeutic areas.

You will bring advanced industry experience and expertise in the fundamentals of Medical Safety practices and processes to Olympus and will report directly to the Medical Safety Director as a member of the global medical safety team.  Additionally, you will be expected to mentor and train other Medical Safety professionals and will use your established expertise to further define medical safety engagement criteria in processes throughout the Olympus product lifecycle.   You must bring strong project management skills, have the ability to manage multiple medical safety projects simultaneously, and must be adept at cultivating strong collaborative relationships across Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care Compliance. 

Job Duties

• Complaint Assessment: Responsible for recognizing the need for, creation, and maintenance of tools, SOPs, and Medical Safety Playbook to be used by yourself and the medical safety team to medically assess causality and severity of adverse events reported to Olympus.  Independently recommends and drives escalation of key events.
• Risk Management: Is considered an expert in risk management principles, playing a key role as medical subject matter expert in the development of pre/post market risk assessments and risk management file documentation, specifically providing information related to observed and potential patient harm, severity, and mitigations to reduce the potential for harm. 
• QARA Processes: Is considered and expert in Medical Safety principles, playing a key role in strategizing and leading efforts to the optimize medical safety's role in QARA processes across the product life cycle. Additionally, provides Medical Safety review and approval for PMS documentation, labeling/IFU creation, Clinical Evaluation Reports, developing responses to inquiries from regulators, Human Factors Engineering reports, non-conformance dispositions, and CAPA.
• Cross-functional Meetings: Provides clear and expert technical leadership, representing Medical Safety in cross-functional meetings related to HHA, FCA, trending, and complaint review boards; independently recognizes and collaborates cross-functionally to drive the escalation of key events or issues with the potential for safety impact. Proactively generates or seeks appropriate data and/or information to quickly facilitate medically sound decisions related to patient safety. 
• Management of Medical Safety or cross-functional projects: Plays an active role in leading Medical Safety priorities and initiatives, aligning goals and performance with business and functional objectives. Clearly and concisely updates functional and senior leadership to project advancements and/or issues with appropriate consideration of the audience to instil trust and confidence. 
• Use your advanced clinical knowledge and medical safety expertise to serve as a medical safety expert contributor to assess and understand product risk and influence and advise on mitigation strategies.
• Search, review, trend, understand, and interpret adverse event data, literature, and other safety-relevant data for the purpose of signal detection.
  
  

Job Qualifications

Required:

• BS/BA Degreed Health Care Professional Required – Advanced Degree Strongly Preferred.
• Minimum of 7 years of professional experience working as a Health Care Professional (RN). DNP, PA-C preferred.
• Direct patient care experience is required (Hospital, Medical or Clinical Practice, with a preference for clinical experience in the areas of Gastroenterology, Pulmonary, ENT, General Surgery, Neurological Surgery, Orthopaedic Surgery, Urology, Obstetrics/Genecology, Infectious Disease, Infection prevention and control).                                                                 
• Minimum of 5 years Medical Safety or Risk Management Experience (Medical Device preferred to Pharma).
• Extended periods of time doing computer-based work
• Extended hours to accommodate international / intercontinental global time schedules.
• While performing the duties of this job, the employee is regularly required to be independently mobile.
• The employee is also required to interact in-person and virtually with peers and co-workers.
• Remote position, preference for midwest or east coast. 
• Travel up to 10% may be required.