Program Manager - Medical Device Safety Operations at Olympus Corporation of the Americas in Westborough, MA
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 Description In collaboration with the Medical Safety Officer, ideal candidate will be 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 Provide 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 Job Requirements REQUIRED EDUCATION:
Bachelor's degree in science or clinically related field . Advanced degree preferred. 5
years of pharmaceutical or device industry or hospital administration 2
years of R&D, Clinical, Pharmacovigilance or medical device safety operational, program management experience, ideally both pre- and post-marketing experience PREFERRED
Qualifications:
Occasional domestic and international travel may be required
Salary Range:
$80K -- $100K
Minimum Qualification
Program Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Bachelor's degree in science or clinically related field . Advanced degree preferred. 5
years of pharmaceutical or device industry or hospital administration 2
years of R&D, Clinical, Pharmacovigilance or medical device safety operational, program management experience, ideally both pre- and post-marketing experience PREFERRED
Qualifications:
Occasional domestic and international travel may be required
Salary Range:
$80K -- $100K
Minimum Qualification
Program Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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