Merck & Co., Inc
Clinical Safety Risk Management Senior Medical Associate-DRU000669
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.
Performs primary medical review of serious adverse experience reports and other AE reports of interest to monitor and describes the safety profile of assigned products; taking an active role in the oversight and development of pharmacovigilance and risk management plans under the overall direction of the CSRM physician/senior management.. Leads preparation regulatory documents and responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for Merck marketed products; strategizes with safety team recommending appropriate data to respond to queries and analyze data.
- Undergraduate degree in nursing (BSN), pharmacy, Physician's Assistant, or other relevant clinical health related field AND Graduate degree in a relevant clinical health related field.
- Graduate degree in nursing (e.g MSN), PharmD, Physician's Assistant, or other relevant clinical health related field (undergraduate training is flexible with advance degree in medical discipline)
- Clinically relevant medical experience in the undergraduate or graduate program is essential (e.g. nursing, pharm D, PA, or other relevant clinical health-related field).
- At least two years of clinical, pharmaceutical industry or related experience is required.
- Excellent writing and communication skills a must.
- Previous experience in a pharmaceutical company analyzing safety data and authoring regulatory documents such as period safety update reports preferred.
- Experience in data analysis or the interpretation of adverse experience information is a plus.
- Strong acumen in use of data analytic tools.
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/Dvcs Sfty Survnce (NonMD)
Job Title:Sr. Scientist, Drug Safety
PRIMARY LOCATION: NA-US-PA-Upper Gwynedd
EMPLOYEE STATUS: Regular
TRAVEL: Yes, 10 % of the Time
NUMBER OF OPENINGS: 1
Company Trade Name:Merck
Merck & Co., Inc
Website : http://www.merck.com
Merck has a long and rich history of working to improve people's health and well-being. Through the years, our researchers have helped to find new ways to treat and prevent illness - from the discovery of vitamin B1, to the first measles vaccine, to cold remedies and antacids, to the first statins to treat high cholesterol. Our scientists also have helped develop many products to improve animal health, including vaccines and antibiotics. /images/merck-history-timeline-screen.jpgWhile we are proud of our past, we are enthusiastic about the future of this new company and we are excited to help create a healthier, brighter future for people around the world.