Senior Safety Operations Manager
Company: Olympus Corporation of the Americas
Location: Southborough
Posted on: January 15, 2021
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Job Description:
*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. *Job DescriptionIn
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. Job Duties* 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 OfficeManage 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.Job
Requirements*REQUIRED QUALIFICATIONS:* * 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. *PREFERRED QUALIFICATIONS:* * 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. *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 -- #Recruit
Keywords: Olympus Corporation of the Americas, Boston , Senior Safety Operations Manager, Executive , Southborough, Massachusetts
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