Director, Clinical Safety & Risk Management (Medical Assessment) Job
- Employer
- Merck
- Location
- Upper Gwynedd PA
- Closing date
- Oct 19, 2017
View more
- Sector
- Business and Finance, Science, Veterinary Medicine, Pharmaceutical, Pharmacovigilance
- Organization Type
- Clinical Practice
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Job Details
Director, Clinical Safety & Risk Management (Medical Assessment)-DRU000656
Description
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.
Under the general direction of the Clinical Safety and Risk Management (CSRM) Physician, the CSRM Medical Assessment Physician is an expert in drug and/or vaccine safety and is responsible for the medical assessment of product quality observations / deviations for the Company’s marketed drugs and vaccines.
The incumbent will work closely with colleagues in Merck Manufacturing Division (MMD) Product Quality and Global Safety & Environment during the investigation of product quality complaint reports and GMP non-compliance events to evaluate potential patient safety impact, and provide medical subject matter expertise during Investigative Review, Fact-Finding and Recall meetings.
Partners with Risk Management Safety Teams to ensure efforts are aligned with global risk management strategies for Company products.
This role will work with the CSRM Group Lead to plan and implement the evolving direction for the medical assessment function of the department, as well as helping develop and align processes to support the department objectives.
Qualifications
Education:
- MD/DO or equivalent
Required:
- Minimum three (3) years Clinical experience
- Must have excellent communication, writing and analytic skills
- Drug safety / pharmacovigilance, pharmaceutical industry experience
Preferred:
- Board certification highly desirable
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.
If you need an accommodation for the application process please email us at staffingaadar@merck.com.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Drug Safety Surveillance (MD)
Job Title:Sr. Principal Scientist, Drug Safety
Primary Location: NA-US-PA-Upper Gwynedd
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 2
Company Trade Name:Merck
Description
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.
Under the general direction of the Clinical Safety and Risk Management (CSRM) Physician, the CSRM Medical Assessment Physician is an expert in drug and/or vaccine safety and is responsible for the medical assessment of product quality observations / deviations for the Company’s marketed drugs and vaccines.
The incumbent will work closely with colleagues in Merck Manufacturing Division (MMD) Product Quality and Global Safety & Environment during the investigation of product quality complaint reports and GMP non-compliance events to evaluate potential patient safety impact, and provide medical subject matter expertise during Investigative Review, Fact-Finding and Recall meetings.
Partners with Risk Management Safety Teams to ensure efforts are aligned with global risk management strategies for Company products.
This role will work with the CSRM Group Lead to plan and implement the evolving direction for the medical assessment function of the department, as well as helping develop and align processes to support the department objectives.
Qualifications
Education:
- MD/DO or equivalent
Required:
- Minimum three (3) years Clinical experience
- Must have excellent communication, writing and analytic skills
- Drug safety / pharmacovigilance, pharmaceutical industry experience
Preferred:
- Board certification highly desirable
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.
If you need an accommodation for the application process please email us at staffingaadar@merck.com.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Drug Safety Surveillance (MD)
Job Title:Sr. Principal Scientist, Drug Safety
Primary Location: NA-US-PA-Upper Gwynedd
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 2
Company Trade Name:Merck
Company
Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.
We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work
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