Principal Scientist, Device Risk Management and Reportability Assessment

Date: Jul 1, 2019

Location: Upper Gwynedd, PA, US

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Requisition ID: DRU001016

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 

Essential functions include, but are not limited to:

Under direction of the Medical Safety Lead for Devices and Product Quality, this position is responsible for providing medical safety subject matter expertise for device risk management in partnership with Product Development, Merck Manufacturing Division (MMD) and the CSRM Risk Management Safety Team (RMST).  Accountable to perform in-line medical assessment of device-component patient risk potential to support individual case safety report (ICSR) reportability determination.  This position is also responsible for supporting departmental activities related to policies and procedures to ensure compliance with global medical device regulations as they pertain to Merck drugs, vaccines, medical devices, drug-device combinations and vaccine-device combinations.  

Highly advanced understanding of safety/risk management to demonstrate primary responsibility for assigned departmental processes and SOPs under the direction of the Executive Director. Empowered representative of CSRM department on cross functional process teams.

Primary Activities, including, but are not limited to:

The Principal Scientist, Device Risk Management and Reportability Assessment will provide in-line medical safety review of ICSRs arising from the conduct of clinical trials and solicited/spontaneous post-marketing safety and product quality complaints.  Associated responsibilities include:
• Development and maintenance of product specific reportability matrices to ensure consistent reporting of malfunctions based on historical sentinel events.
• Development and maintenance of MedDRA groupings for ICSR screening for assessment.
• Performance of in-line ICSR review, in partnership with Global Safety Case Management and MMD Quality Assurance Complaint Handling and Investigation, to determine if expedited reporting criteria has been satisfied.
• Escalation, execution and communication of reportability matrix updates upon identification of a sentinel device malfunction/serious injury pair.
• Partner with Risk Assessment Physician in escalation of ICSR to RMST.

The Principal Scientist, Device Risk Management and Reportability Assessment will provide medical insights to the device risk management development and review in the following settings:
• Partner with MDCP Quality to update malfunction occurrence rates based on what has been observed in complaints relative to historical occurrence.
• Establish and update Hazard and Harms Listings for utilization in device risk management, characterizing the nature of potential device-associated harms and the potential severity levels of harms.
• Participate establishment of risk management documentation in new product development for novel drug and/or device platforms in partnership with CSRM Product Physician.  This includes contribution to the Device Risk Management Plan, Device Design Failure Mode Effects Analysis and Device Risk Management Summary.
• Partner with RMST in labeling assessment and updates associated with device risk management outcomes.
• Partner with Risk Assessment Physician in implementation of updates to product risk management required as output of Health Hazard Evaluation/Health Risk Assessment.

Extended Activities, including, but are not limited to:
• Partner with CSRM Product Physician and Medical Associate, Device and Product Quality Surveillance and Risk Assessment in data review, development and maintenance for Clinical Evaluation Reports.
• Provide expertise and guidance in development, maintenance and use of MedDRA term selection guidance for ICSRs to capture device-related information.
• Contribute to Health Authority responses specific to device risk management as ad hoc member of RMST.


• M.D. or D.O. with minimum of 3 years of combined clinical practice and pharmaceutical/medical device industry experience of which a minimum of 1 year MUST include safety experience.
• Advanced degree healthcare professionals (e.g. MSN, CRNP, PA, PharmD) with a minimum of 8 years of combined clinical practice and pharmaceutical/medical device industry experience of which a minimum of 5 years MUST include safety experience.   

• A minimum of 2 years of medical device and/or combination product experience, including device risk management
• Prior medical review and/or case management experience specific to medical device case reporting 
• Experience as interface with manufacturing and/or medical device design
• Excellent writing and communication skills a must. 
• Demonstrated leadership skills in managing programs, processes, and facilitating meetings.  Problem solving, compliance mindset and critical thinking skills.

• Experience in data analysis or the interpretation of adverse experience information and aggregate safety data
• Experience in authoring of safety documents is a plus  

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 


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Job: Drug Safety Surveillance (MD)
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings: 1
Shift (if applicable):
Hazardous Materials: no
Company Trade Name: Merck

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