Principal, Medical Safety Specialist

Job Description

As a Principal Medical Safety Specialist (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 execute upon Olympus medical safety processes globally. 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 solid 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.

Job Duties

• Complaint Assessment: Contribute to the creation of tools and SOPs to be used by the medical safety team to medically assess causality and severity of adverse events reported to Olympus. Independently recommend escalation of key events.
• Risk Management: Uses prior risk management experience to contribute to 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: Uses prior Medical Safety experience to contribute to the optimization of medical safety's role in QARA processes across the product life cycle by participating in activities to formalize and optimize the MS role. 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: Independently uses medical subject matter expertise to represent Medical Safety in cross-functional meetings related to HHA, FCA, trending, and complaint review boards; independently recognizes and contributes to escalation of key events or issues with potential for safety impact. Identifies data or information needed to facilitate medically sound decision making related to patient safety.
• Medical Safety or Cross-functional projects: Plays an active role in driving and contributing to Medical Safety priorities and initiatives, aligning goals and performance with business and functional objectives. Will often lead initiatives and internally communicate progress on assigned initiatives.
• Search, review, trend, understand, and interpret adverse event data, literature, and other safety-relevant data for the purpose of signal detection.

Job Qualifications

• BS/BA Degreed Health Care Professional Required
• 5+ years of experience working as a Health Care Professional (RN).
• 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)
• 4+ 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.
• Travel up to 10% may be required.
• Able to lead with influence without authority.
• Personal integrity, ethics, and honesty
• Excellent written and spoken English.
• Able to successfully influence and collaborate cross-culturally.
• Fluency with medical terminology and proficiency in medical writing
• Results oriented mindset.
• Demonstrated attention to detail.
• Strong problem-solving and excellent organizational skills
• Able to prioritize rapidly.
• Aptitude to make decisions and execute directives.
• Profiency in common MS Office programs (Word, Excel, PowerPoint, Teams)
• Able to listen and think critically (sometimes creatively)
• Proficiency in public speaking and delivering presentations.
• Experience working in a matrix management structure.
• Excellent decision making/analysis skills; ability to manage multiple projects simultaneously.
• Able to be an initiative-taker and work independently to achieve on time deliverables.
• Maturity to consistently balance a sense of urgency with diplomacy & empathy.
• A keen sense of intuition to anticipate problems before they occur.
• Wherewithal to work under tight deadlines, demonstrating initiative and flexibility.
• Effective people skills that allow cultivation of working relationships that may or may not be part of direct team (cross functional environment).