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Senior Manager, Medical Safety

Req ID:  3712

Working Location: PENNSYLVANIA, CENTER VALLEY; FLORIDA, MIAMI; MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; Nationwide; TENNESSEE, BARTLETT; TEXAS, WEBSTER 

 

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 Senior Manager (MSSM) is integral to the day-to-day functioning and developmental success of the global medical safety organization. In this vital role the MSSM will facilitate, develop, lead, and execute upon an encompassing range of medical safety processes across Olympus. As a leader the MSSM will shape both the science and practice of all professional medical safety activities related to the detection, assessment, understanding of product risks and their effective mitigations to protect patients worldwide. The MSSM will come to be regarded as both an internal and external expert focused on both individual and team successes.

 

The MSSM will report directly to the Chief Medical-Safety Officer and will work closely with the global medical safety leadership team. The successful candidate will be adept at cultivating strong collaborative relationships across Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, as well as Health Care Compliance and will be required to effectively deliver medical knowledge and clinical insights across the product lifecycle for all Olympus therapeutic areas.

Job Duties

* Serve as a medical safety expert advisor to assess, understand, product risk and advise on mitigation strategies.

 

* Search, review, trend, understand, and interpret adverse event data, literature, and other safety-relevant data for the purpose of signal detection.

 

* Demonstrate knowledge and experience working with:

  • * Various regulations (HIPPA, EU-MDR, FDA CFR 803).
  • * Various standards (GCP, ISO 13485, ISO 14971).
  • * Regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs, PSURs).
  • * Corrective Actions – Preventative Actions (CAPAs).
  • * Health Hazard Assessment & Field Corrective Actions.
  • * Resolving product non-conformances.
  • * MedDRA dictionary terms and proficiency in adverse event coding and reporting.
  • * Post market surveillance, escalations, and mandatory safety reporting requirements.
  • * Endoscopic diagnostic and therapeutic procedures in the following therapeutic areas: Gastroenterology, Pulmonary, ENT, General Surgery, Neurological Surgery, Orthopaedic Surgery, Urology, Obstetrics/Genecology, Infectious Disease, Infection prevention and control..

 

* Development and maintain Medical Safety standard operating procedures, guidance, work instructions, training, and competencies.

 

* Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental, cross functional teams and resolve quality-related issues in a timely and effective manner.

 

* Demonstrate experience staying engaged with worldwide clinical practice guidelines, safety requirements, and procedures of global Competent Authorities.

Job Requirements

REQUIRED QUALIFICATIONS

Bachelor's degree required.

 

* Masters or doctorate degree (DNP, PhD, MD, or equivalent).

 

* Minimum of 3 years of direct patient care experience required (Hospital, Medical, or Clinical Practice).

 

* One or both of the following specific Medical Safety experiences required:

    * Minimum of 3 years of Medical Safety (Medical Device preferred to Pharma) experience.

    * Minimum of 3 years of Risk Management (Medical Device) experience.

 

Other Considerations (travel/hours availability, etc.): Extended hours to accommodate international/intercontinental global time schedules Travel up to 20-25% maybe required.

 

PREFERRED QUALIFICATIONS

* Excellent written and spoken English.

 

* Fluency with medical terminology and proficiency in medical writing.

 

* Ability to make decisions and execute directives.

 

* Demonstrated proficiency with common MS Office programs (Word, Excel, PowerPoint, Teams).

 

* Proficiency in public speaking and delivering presentations.

 

* Demonstrated project management skills.

 

* Excellent decision making/analysis skills; ability to manage multiple projects simultaneously.

 

* Effective interpersonal skills that allow cultivation of working relationships that may or may not be part of direct team (cross functional environment).

 

* Ability to lead with influence as well as authority.

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) || Pennsylvania (US-PA) || Center Valley || 


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