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Medical Safety Associate

Req ID:  751

Working Location: MASSACHUSETTS, LITTLETON; MASSACHUSETTS, SOUTHBOROUGH; MASSACHUSETTS, WALTHAM; PENNSYLVANIA, BREINIGSVILLE; PENNSYLVANIA, CENTER VALLEY; PENNSYLVANIA, STATE COLLEGE 

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

The Medical Safety Associate is primarily responsible for providing medical safety and clinical expertise regarding product usage and performance of products.  This position will continually monitor the safety and risk/benefit profile of products marketed and sold by Olympus to ensure proactive safety surveillance across the product lifecycle.  The Medical Safety Associate will provide the initial triage and assessment of medical safety issues and will be responsible for escalation of any medical safety issues to the Medical Safety Director and Chief Medical Safety Officer.  The Medical Safety Associate will collaborate across all business leaders and functions within Olympus including, but not limited to, Medical/Clinical, Quality, Regulatory, R&D, and across all regions.

Job Duties

* Provides clinical and safety review and assessment of safety events and issues across all products of Olympus.
 

* Assists Quality Assurance and Medical Affairs in addressing complex medical inquiries including off-label issues.


* Evaluate post-market surveillance Adverse Events and medical/scientific literature to identify potential safety issues and continued risk/benefit assessment.
 

* Review competent authority requests related to medical safety issues, risk-benefit assessment, and aid in timely response.
 

* Compose and maintain medical communications related to specific safety events and risk/benefit assessment.  
 

* Retrieve, disseminate, and archive pertinent safety data to appropriate parties.
 

* Participate on cross-functional teams providing medical safety input across the areas of research and development, risk management, quality/complaints, medical affairs, clinical research, regulatory and quality assurance.
 

* Provide medical safety consultation in matters related to safety, risk/benefit, and proper product safety usage as needed.
 

* Provide support for post-market risk analysis and/or Health Hazard Evaluations as needed.
 

* Comply with all relevant related guidelines, standards and regulations pertaining to medical safety information.
 

* Assist in the development and maintenance of the standard operating procedures for the medical safety office.  
 

* Escalation and collaboration with the Medical Safety Directors and Medical Safety Officer on product medical safety issues.
 

* Collaboratively and effectively communicate with various departments, including Clinical/Medical, Legal, Regulatory Affairs, Quality, R&D, Engineering, business leaders on relevant medical safety issues and medical safety updates as appropriate.
 

* Manage medical safety event metrics and data to support resourcing and operational continuous improvement for the function.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor’s Degree in Nursing or PharmD; Advanced degree preferred.

 

* 20% travel and on-site monitoring are to be expected.

 

* Minimum of 5 years of patient care experience; experience in the relevant areas of endoscopy, GI, respiratory, or urology preferred.

 

* Minimum 2 years of experience in review of clinical medical event information or risk assessments, and experience in the medical device industry preferred.

 

* Operating room procedure and Olympus product familiarity preferred.

 

PREFERRED QUALIFICATIONS:

 

* Ability to perform medical safety patient assessments.

 

* Advanced ability to read, analyze and interpret clinical/medical information.

 

* Well-developed written and communication skills.

 

* Strong organizational skills with the ability to prioritize task and meet deadlines.

 

* Effective analytical and problem solving.

 

* Knowledge and proficient use of Microsoft Office Suite Applications (Word, Excel, Power Point, and Microsoft Project).

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’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.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) || Littleton || 


Nearest Major Market: Boston

Job Segment: Engineer, QA, Quality Assurance, R&D Engineer, PLM, Engineering, Quality, Technology, Management

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