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.

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, 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 Qualifications

Required:

• 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.
• Ability to lead with influence without authority.
• Personal integrity, ethics, and honesty
• Excellent written and spoken English.
• Ability 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
• Ability to prioritize rapidly.
• Aptitude to make decisions and execute directives.
• Demonstrated proficiency with common MS Office programs (Word, Excel, PowerPoint, Teams)
• Ability 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.
• Ability 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).

Preferred:

• Advanced degree preferred.
• DNP, PA-C preferred.

Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on:

• Competitive salaries, annual bonus and 401(k)* with company match

• Comprehensive medical, dental, vision coverage effective on start date

• 24/7 Employee Assistance Program

• Free live and on-demand Wellbeing Programs

• Generous Paid Vacation and Sick Time

• Paid Parental Leave and Adoption Assistance*

• 12 Paid Holidays

• On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

• Work-life integrated culture that supports an employee centric mindset

• Offers onsite, hybrid and field work environments

• Paid volunteering and charitable donation/match programs

• Employee Resource Groups

• Dedicated Training Resources and Learning & Development Programs

• Paid Educational Assistance

*US Only **Center Valley, PA and Westborough, MA Are you ready to be a part of our team? Learn more about our benefits and incentives: . The anticipated base pay range for this full-time position is $106,402.00 - $174,963.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual. Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications. At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit . You Belong at Olympus We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply. Let’s realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs