Olympus Corporation of the Americas Chief Medical Safety Officer in Southborough, Massachusetts
Working Location: MASSACHUSETTS, SOUTHBOROUGH; PENNSYLVANIA, CENTER VALLEY
Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day.
Let’s inspire healthier lives, together.
The Chief Medical Safety Officer is responsible for conducting, supervising and managing the independent medical safety and medical risk management review of all products on a global basis. The Chief Medical Safety Officer plays a pivotal role in evaluating customer/user risk and in assessing the real or potential impact of product performance issues on patient safety. The reactive elements of the role (addressing quality/performance issues) are balanced with the need for a proactive approach in continually assessing all available information/data sources and advising on any mitigating activities, which should be taken to minimize potential risk to patients. Will be responsible for driving the implementation of comprehensive medical safety capability including professional staff, systems and process along with a change management initiative to elevate the patient safety culture across Olympus.
The Medical Safety Officer will assess product risk-benefit, and provide medical input/review to Risk Management Reports, Health Hazards Evaluations, Clinical Evaluation Reports, including risk categorization of product/product families.
The Chief Medical Safety Officer is an active member of a cross-functional team and will prepare, submit and review with quality leader’s product post market surveillance data and information to assess product risk profiles, globally.
The Chief Medical Safety Officer will provide input on response to adverse events, complaints and mass communications, review internal and customer safety training materials, input into design and interpretation of safety related studies, evaluation of medical impact of manufacturing issues and clinical interpretation of: post-marketing safety data, aggregate complaint data, individual case safety reports and literature reports with possible safety data.
Provide medical safety expertise, oversight and guidance as it relates to the performance and impact of Olympus products. The Medical Safety Officer will contribute to and continually review the definition of a product's harms and hazards.
The Medical Safety Officer will provide independent review and approve (from a medical safety perspective) of appropriate reports working with the complaint handling unit, advise on failure investigations and provide medical opinion when deciding on reportability.
Monitor external sources/trends and identify and escalate emerging issues.
These include (but are not limited to) complaint & MDR trends and regulatory & market trends/intelligence.
Be the medical representative within the escalation process when making decisions on field actions; and to evaluate the effectiveness of field safety corrective actions.
Ensure consistency in medical evaluations, Quality Review Board decisions and overall safety evaluations of products.
Ensure appropriate metrics are used to assess adequacy of patient safety related processes.
The CMSO will help drive implementation of necessary safety systems, processes & procedures along with robust professional staffing to ensure a proactive, risk-based approach to patient safety and risk management is deployed globally.
A Medical Degree or equivalent degree is required.
The candidate must be licensed to practice medicine and possess appropriate certifications required to practice as a professional in his/her given specialty.
Minimum 10 years of prior, related work experience is required. Prior work experience may include a combination of work within a medical, corporate, or clinical environment.
Strong Executive Presence with the ability to communicate at the highest levels of the organization and the top level of regulatory body leadership.
Experience developing and leading a similar function in a like sized or larger health sciences company.
General knowledge of the regulations and standard practices governing clinical research is required. Past experience with clinical trials/product development is preferred.
Experience in or working with, the medical device industry or a related industry (e.g., pharma) is required.
Prior full-time employment in the medical safety or medical affairs department of a medical device company is preferred.
Experience applying Risk Management principles is preferred.
Prior experience as a primary investigator in a published clinical/scientific research study is preferred.
The incumbent must have a general understanding of statistics.
A general, working knowledge of applicable regulations is preferred.
possess strong interpersonal skills and experience working effectively in a team/matrix environment is preferred.
Strong analytical skills and excellent oral and written communication skills such that the incumbent will be able to work effectively with both internal/external stakeholders including medical professionals and subordinate staff.
Ability to make formal and informal presentations with and without computer aids is required.
We realize work isn’t just a job to you.
It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.
Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.
Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,500 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .
Olympus…True to You. True to Society. True to LIFE.
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) || Massachusetts (US-MA) || Southborough ||