Olympus America Inc. Medical Safety Officer in Southborough, Massachusetts
MD Degree is required.
Must be licensed to practice medicine and possess appropriate certifications required to practice as a professional in his/her given specialty.
Minimum of 10 years of related work experience is required. Prior work experience may include a combination of work within a medical, corporate, or clinical environment.
General knowledge of the regulations and standard practices governing clinical research is required.
Experience in or working with, the medical device industry or a related industry (e.g., pharma) is required.
Ability to make formal and informal presentations with and without computer aids is required.
* Solid project management skills are required.
Past experience with clinical trials/product development is preferred.
Prior full-time employment in the 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.
General understanding of statistics.
General, working knowledge of applicable FDA regulations is preferred.
Ability to work collaboratively with colleagues from a variety of functions and exhibit strong leadership skills.
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.
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.
As a Medical Safety Officer working on the Market Quality team, you will be empowered and inspired to do your best work. You will contribute to our mission by conducting and managing the independent medical safety review of OSTA products.
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.
Serve as 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.
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 OSTA products.
Contribute to and continually review the definition of a product's harms and hazards.
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.
Serve as 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.
At Olympus, we put a lot of good back into the world, and what we do really matters. We are committed to making people’s lives healthier, safer and more fulfilling every day by crafting innovative optical and digital solutions in medical technologies, microscopy, industrial solutions, cameras, and audio recorders.
We view our relationship with and commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our vision, and everyone here helps to make it a reality. We’re invested in our employees, great ideas, and how they impact the communities around us. We see the world through multiple lenses and come together to find the right answers; the best solutions.
TRUE TO YOU. TRUE TO SOCIETY. TRUE TO LIFE.
Olympus Surgical Technology America
Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled
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. We’re currently looking for a Medical Safety Officer to join us in our Southborough, MA office.
Let’s inspire healthier lives, together.
The Medical Safety Officer is responsible for conducting, supervising and managing the independent medical safety review of OSTA products on a global basis. The incumbent is an active member of a cross-functional team, and a close partner of the Quality leaders in assessing any potential safety signals for OSTA products. He/She 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.
Potential to lead and develop Medical and Safety Department to include potentially clinical and/or risk managers and /or professionals.
Olympus Surgical Technology America at http://www.olympus-osta.com/
Southborough GYR ACMI Inc
Medical Safety Officer
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Olympus is an Equal Opportunity Employer, and our policies prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.