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.

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.  

** Remote candidates may be considered dependent upon candidate experience and qualifications.

Job Duties

* 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, Orthopaedic Surgery, Urology, Obstetrics/Genecology, Infectious Disease, Infection Prevention and Control

* Maintain knowledge of Olympus standard operating procedures, guidance, work instructions, training, and competencies

* Participate /initiate/create activities and materials related to onboarding or mentoring members of the Medical Safety team.

* Demonstrate knowledge and experience in working through new product development (stage gates)

* Demonstrate strong self-motivation and individual leadership skills, including the ability to communicate and influence multi-departmental, cross functional teams and contribute to the resolution of quality-related issues in a timely and effective manner

* Demonstrate experience staying engaged with worldwide clinical practice guidelines, safety requirements, and  global Competent Authority regulations. 

* Cultivate Innovation: Creates new and better ways for the organization to be successful

Job Requirements

REQUIRED QUALIFICATIONS:

* BS/BA Degreed Health Care Professional – Advanced Degree preferred.

* You must have 5-10 years of work experience that includes both: 

• Working as Health Care Professional – (RN, DNP, PA-C, MD).  Direct patient care experience is required (Hospital, Medical, or Clinical Practice, etc with a preference for clinical experience in the areas of the Gastroenterology, Pulmonary, ENT, General Surgery, Neurological Surgery, Orthopaedic Surgery, Urology, Obstetrics/Genecology, Infectious Disease, Infection prevention and control)
• Medical Safety (Medical Device preferred to Pharma) or Risk Management (Medical Device) experience 

* 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