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.
• Master's degree in NURSING, PharmD, PA or other relevant clinical health related field.
• Undergraduate degree in NURSING (BSN), pharmacy, Physician's Assistant, or other relevant clinical health related field AND Graduate degree in a relevant health related field. OR
• 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)
• 2 years of 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).
• Previous experience in a pharmaceutical company analyzing safety data and authoring regulatory documents such as period safety update reports.
• Strong acumen in use of data analytic tools.
• Strong writing and communication skills
• Experience in data analysis or the interpretation of adverse experience information is a plus.
• Problem solving and critical thinking skills.
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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