Working Location: MASSACHUSETTS, WESTBOROUGH; PENNSYLVANIA,
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.
Olympus is moving to Westborough, MA! Our brand new Westborough
campus is scheduled for completion on March 15, 2021 and will house
roles that were formerly based out of our Southborough, MA and
Littleton, MA locations. The design of Olympus Westborough
prioritizes an exceptional employee experience, with opportunities
for wellbeing and seamless global collaboration. More information
is available by asking your recruiting team!
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
- 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
- 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
- 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
- Occasional domestic and international travel may be
- Advanced degree preferred.
- Advanced ability to read, analyze and interpret
- 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
- Solid knowledge of medical / clinical processes including
medical safety review processes.
- Strong leadership skills, as well as experience working in a
- Must have a strong working knowledge of FDA regulations/ICH
- Ability to work in a fast-paced environment with demonstrated
ability to simultaneously manage multiple competing tasks and
- 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
OlympusTrue 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
Posting Notes: || United States (US) || Massachusetts (US-MA) ||