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Clinical Trial Medical Reviewer Job

Employer
Merck
Location
Upper Gwynedd PA
Closing date
Feb 3, 2017

Job Details

Clinical Trial Medical Reviewer-DRU000597

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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


Under the direction and oversight of the Head of Medical Safety Review, the Clinical Trial Medical Reviewer will provide in-line medical safety review of individual cases arising from Merck clinical trials in order to: determine or confirm the need for expedited reporting to regulatory agencies, ensure the quality coherence and accuracy of the case narrative, perform a medical assessment of the case in the context of the available safety data and the known safety profile, and provide a company statement and a causality assessment which will be included as part of the Individual Case Report. In order to improve the accuracy and completeness of the case report, the incumbent will also generate medical queries, as needed, which will be communicated to the corresponding site via Clinical Development. While ensuring compliance with global expedited reporting timelines, the Clinical Trial Medical Reviewer will also consult with the Clinical Director for the trial and with the Clinical Safety and Risk Management (CSRM) Physician, as needed, for cases requiring additional clinical or safety subject matter expertise. The Clinical Medical Reviewer will work closely and collaboratively with colleagues in other Merck departments, including but not limited to: Clinical Safety Scientists, Clinical Directors in Clinical Research, CSRM Physicians, and CSRM Associates and Scientists, and Global Safety Case Management. The Clinical Medical Reviewer will be an extended member of the Risk Management Safety Teams (RMST’s) for the products that he/she supports, and other relevant sub-teams. The incumbent will be based at Merck site in Rahway (NJ) or Upper Gwynedd (PA).

Qualifications

Education:

- M.D., D.O., or equivalent

Required:

- Minimum of 3 years: clinical practice experience, following training or prior industry experience in safety, clinical development and/or medical affairs

Preferred:

- Board certification
- Experience in drug safety, pharmacovigilance and/or risk management is highly desirable
- Prior medical review and/or case management experience
- Drug development experience (early or late phase clinical research, regulatory affairs, and/or safety/PV)

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. 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:Prin. 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: 1

Shift (if applicable): N/A

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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