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Clinical Safety and Risk Management (CSRM) Senior Scientist Job

Job Details

Clinical Safety and Risk Management (CSRM) Senior Scientist-DRU000634

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 125-year legacy. 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.

Works in conjunction with the Clinical Safety and Risk Management (CSRM) associate and physician in the safety surveillance of assigned products. With increased independence, performs the data retrieval, data preparation, and preliminary analysis for responses to inquiries from health professionals, regulatory agencies and other customers regarding adverse experiences reported with Merck products. This includes authoring of regulatory documents. Under the direction of the CSRM physician/senior staff, assists with the safety surveillance review of safety data such as adverse experience reports and assists with the development and evaluation of risk management plans (RMPs).

Primary activities include, but are not limited to:

1. Strong working knowledge and understanding of safety surveillance/Pharmacovigilance and epidemiologic principles, assisting the CSRM team with the following activities;

1. Periodic review of adverse experience (AE) reports in support of the Adverse Experience Review (AER) process including presentation of safety data to the Risk management Safety Team ( RMST)
2. Work independently to prepare data for retrieval and analysis. This may include querying the safety surveillance database, preparing spreadsheets for interpretation and review of data output.
3. Increased independence in authoring agency responses and regulatory documents such as periodic safety update reports (PSURs), risk management plans (RMPs) and the Clinical Overviews summarizing relevant findings to support regulatory responses.
4. Work independently to author medical responses under the guidance of CSRM staff.
2. Familiar with RMPs and regulatory guidances to support CSRM activities; contributes to the development, authoring, implementation and/or evaluation of RMPs.
3. Complete understanding and participation in the submission process for regulatory documents and publications.
4. Capable of responding to requests posed by internal customers.
5. Manage programs and registries with primary ownership.
6. Complete understanding of the label validation process, including MedDRA, and independent review of the product label for participation in this process. Expanded knowledge/Subject Matter Expert on the use of computer software programs (e.g. Excel, Word, PV Reports, PV Analytics, STAR, RCAM, MARRS, etc) to assist with data capture and analysis.
7. Under the guidance of CSRM staff conducts literature reviews, identify background population rates and summarize relevant findings to support regulatory responses and PSURs.
8. Communicate and provide information to various inter-disciplinary teams regarding safety evaluation and risk management throughout clinical, submission and post-marketing phases.
9. Participate in departmental and inter-departmental meetings and committees, as appropriate.

Qualifications

Education:

- Bachelor’s degree in nursing, pharmacy or other relevant field is required and six years of professional experience that includes both clinical and pharmaceutical experience. The pharmaceutical experience should include a minimum of 3 years of relevant Safety/Pharmacovigilance experience in the review of aggregate safety data and authoring of safety documents -OR-
- Bachelor’s degree in nursing, pharmacy or relevant field is required with a relevant master’s degree and 4 years professional experience that includes both clinical and pharmaceutical experience. The pharmaceutical experience should include a minimum of 3 years of relevant Safety/Pharmacovigilance experience in the review of aggregate safety data and authoring of safety documents.

Required:

- This position requires excellent writing and verbal communication skills, problem solving ability, and analytical skills.
- Proficiency with Microsoft program package (Word, Excel, and PowerPoint) required

Preferred:

- Data management, quality assurance, and compliance experience 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:

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EEOC GINA Supplement​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Drug/Dvcs Sfty Survnce (NonMD)

Job Title:Sr. Scientist, Drug Safety

Primary Location: NA-US-PA-Upper Gwynedd

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 5 % 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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