Clinical Safety and Risk Management (CSRM) Senior Scientist Job - United States
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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.
- 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.
- 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
- 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 firstname.lastname@example.org.
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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
Nearest Major Market: Philadelphia
Job Segment: Clinic, Epidemiology, Scientific, Risk Management, Medical, Healthcare, Engineering, Finance