Olympus Corporation of the Americas Senior Safety Operations Manager 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.
In collaboration with the Medical Safety Officer, responsible for developing and managing the medical safety operational activities at the group level. Responsibilities include development and oversight of medical safety processes and procedures, resource planning, budgets, performance metrics, safety reporting, safety systems, and continuous improvement initiatives for the medical safety office. This position will serve as the senior operations manager of the group safety team and will ensure critical cross functional collaboration throughout the business and functions of Olympus to deliver on the key medical safety requirements and global medical safety roles and standards processes supporting the various regions and businesses.
Global medical safety operations representative leading development, oversight, and management of global safety resources, processes, tools, and systems enabling consistent, standardized, and proactive medical safety across the product lifecycle.
Providing expert guidance regarding medical safety operational activities.
Collaborate with functional leaders across Olympus and respective businesses to establish, communicate, and monitor key medical safety activities, requirements, and decisions from the Group Safety Office
Manage the development, deployment, and compliance monitoring of safety processes for the safety functions across Olympus.
Recruit, manage, and develop internal safety staff within the medical safety office.
Develop, maintain, and implement group level safety policies and procedures to ensure compliance with global regulations and requirements.
Provide guidance to staff regarding optimal practice of collection, evaluation and processing of adverse experience reports, from a medical safety perspective.
Contribute to preparation and review of management reports such as periodic group Safety dashboards and escalation documentation.
Manage group-level partner /affiliate safety agreements and interactions, as needed.
Participates in external industry forums and communicates any insights and upcoming changes in regulations impacting medical safety activities across Olympus .
Prepares, tracks, and manages group safety budget, resource planning, and performance metrics.
Promotes use of efficient processes, systems, and tools across the global medical safety office.
Leads strategic global initiatives impacting medical safety across the company.
Perform other duties as assigned.
Bachelor’s degree in science or clinically related field.
Advanced degree preferred.
Minimum 5 years of pharmaceutical or device industry.
Minimum 2 years of R&D, Clinical, Pharmacovigilance or other Safety operational experience, ideally both pre- and post-marketing experience.
Occasional domestic and international travel may be required.
Advanced degree preferred.
Advanced ability to read, analyze and interpret clinical/medical information.
Possess very strong writing skills and advanced verbal communication and presentation skills.
Proven skills in managing and growing a diverse team.
Requires strong attention to detail in writing and/or proofing materials.
Solid knowledge of medical / clinical processes including medical safety review processes.
Strong leadership skills, as well as experience working in a matrix environment.
Must have a strong working knowledge of FDA regulations/ICH guidelines.
Ability to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
Ability to work independently; take initiative and complete tasks to deadlines.
Innate desire to focus on patient outcomes.
Collaborative work style.
Managerial courage including the ability to make tough calls in situations that may be controversial.
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 at https://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 ||