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. ****Remote candidates will be considered based on experience and qualifications. 

You will bring 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 expertise to contribute to the definition and formalization of medical safety engagement criteria in processes throughout the Olympus product lifecycle. You 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: 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 recommends 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. 
• Use your advanced clinical knowledge and medical safety experience 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 
• You will demonstrate in-depth knowledge and experience working with: Various regulations (HIPPA, EU-MDR, FDA 21 CFR Part 803, 806, 820); Various standards (GCP, ISO 13485, ISO 14971); Regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs, PSURs); Corrective Actions – Preventative Actions (CAPAs); Health Hazard Assessment & Field Corrective Actions; Resolving product non-conformances; IMDRF dictionary terms and proficiency in adverse event coding and reporting; Post market surveillance, escalations, and mandatory safety reporting requirements; Endoscopic diagnostic and therapeutic procedures in the following therapeutic areas: Gastroenterology, Pulmonary, ENT, General Surgery, Neurological Surgery, Orthopedic Surgery, Urology, Obstetrics/Genecology, Infectious Disease, Infection Prevention and Control 

Job Qualifications

Required:

• BS/BA Degreed Health Care Professional Required – Advanced Degree 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, Orthopedic Surgery, Urology, Obstetrics/Genecology, Infectious Disease, Infection prevention and control).
• Minimum of 4 years Medical Safety or Risk Management Experience (Medical Device preferred to Pharma).
• 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.

Preferred:

• Minimum of 5 years of experience working as a Health Care Professional (RN). DNP, PA-C preferred.
• Extended periods of time doing computer-based work

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