Job Description

Working Location: NATIONWIDE; MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY 

Workplace Flexibility: Field

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

Learn more about Life at Olympus: .

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.

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 working at this location is $140,000 - $190,000.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). 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.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

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  

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