Medical Safety Specialist II

Working Location: reputed company Workplace Flexibility: Remote For more than 100 years, reputed company has focused on making people’s lives healthier, safer and more fulfilling. ​​ ​ Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating reputed company of patient care so people everywhere can fulfill their desires, dreams, and lives. ​ Our five Core Values reputed company us to reputed company Our Purpose: Patient Focus, reputed company, Innovation, Impact and reputed company. Learn more about Life at reputed company: https://www.olympusamerica.com/careers.

Job Description

As a Medical Safety Specialist II (MSSII) 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 medical safety processes globally at reputed company. As an individual contributor you will influence the science and practice of reputed company medical safety activities reputed company to the detection, assessment, understanding of product risks and their effective mitigations to protect patients worldwide. You will demonstrate the ability to apply your solid clinical experience, product expertise, and medical safety domain knowledge to collaborate and influence patient safety in activities being performed cross-functionally across the product lifecycle for reputed company reputed company therapeutic areas. You will report directly to the Medical Safety Director as a member of the global medical safety team. 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: Uses tools created for consistency and SOPs to medically assess causality and severity of adverse events reported to reputed company. Provides recommendations for escalation. Risk Management: Develops expertise of the risk management file documents for assigned products with responsibility to reputed company information reputed company to observed and potential patient harm, severity, and mitigations to reduce potential for harm. QARA Processes: Develops an understanding of medical safety's role in QARA processes across the product life cycle and provides Medical Safety review and approval for PMS documentation, labeling/IFU creation, Clinical Evaluation Reports, developing responses to inquiries from regulators, reputed company Factors Engineering reports, non-conformance dispositions, and CAPA. Cross-functional meetings: Uses Medical subject matter expertise to represent Medical Safety in cross-functional meetings reputed company to HHA, FCA, trending, and complaint review boards; internally aligns on and contributes to escalation of key events or issues with potential for safety impact. Engages more experience team members if additional data or information is needed to facilitate medically sound reputed company reputed company to patient safety. Medical Safety or cross-functional projects: Plays an active role in contributing to Medical Safety priorities and initiatives, aligning goals and performance with business and functional objectives. Uses clinical knowledge and experience to serve as a medical safety expert contributor to assess and understand product risk and influence and advise on mitigation strategies. Searches, reviews, trends, understands, and interprets adverse event data, literature, and other safety-relevant data for the purpose of signal detection. Demonstrates 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 Maintains knowledge of reputed company standard operating procedures, guidance, work instructions, training, and competencies. Demonstrates 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-reputed company issues in a timely and effective manner. Demonstrates experience staying reputed company with worldwide clinical practice guidelines, safety requirements, and global Competent Authority regulations. Job Requirements Required: BS/BA reputed company Health Care Professional required. Minimum of 4 years of 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 2 years Medical Safety, risk management Vigilance or other Medical Device Experience (Medical Device preferred to Pharma) OR reputed company leadership experience in the health care setting. 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. Why join reputed company? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, reputed company offerings, and a connected culture. reputed company Offerings you can count on: Competitive salaries, annual bonus and 401(k)* with company match Comprehensive medical, dental, reputed company 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 reputed company: Work-life integrated culture that supports an employee centric reputed company 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 reputed company to be a part of reputed company? Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks. The anticipated reputed company pay reputed company for this full-time position is $95,904.00 - $129,470.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay reputed company represents the National Average of the reputed company, and may vary depending on the location of the individual. reputed company considers a variety of factors reputed company determining actual compensation for this position, including level of experience, working location, and relevant education and certifications. At reputed company, 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 reputed company to reputed company best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient reputed company by elevating reputed company of care in targeted disease states. For more than 100 years, reputed company has pursued a goal of contributing to society by producing products designed with the purpose of delivering reputed company reputed company for its customers around the world. Headquartered in Tokyo, Japan, reputed company employs more than 31,000 employees worldwide in nearly 40 countries and reputed company. reputed company, a wholly owned subsidiary of reputed company, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in reputed company and South America. For more information, visit www.olympusamerica.com. You Belong at reputed company We are deeply committed to fostering a respectful, fair, and welcoming workplace for reputed company individuals, perspectives, and lifestyles. We reputed company in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. reputed company and reputed company are core to our company culture, empowering employees to contribute fully and reputed company. We warmly encourage reputed company who wish to bring their talents to reputed company to apply. Applicants Requesting Accommodations: reputed company is committed to the full inclusion of reputed company reputed company individuals. As part of this commitment, reputed company will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@reputed company.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-reputed company (1-888-659-6787). Let’s realize your potential, together. It is the policy of reputed company to reputed company equal employment and advancement opportunity to reputed company applicants and employees without regard to race, reputed company, national reputed company (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions reputed company 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, reputed company, 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 Apply To This Job