Clinical Safety Risk Management, Senior Medical Associate 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.
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.
- 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).
- A minimum of 6 years of professional experience with both clinical and pharmaceutical industry experience required, of which a minimum of 3 years MUST include safety experience .e.g. PV or clinical) involving analysis of aggregate safety data and authoring of safety documents.
- Excellent writing and communication skills a must.
- Demonstrated leadership skills in managing programs, processes, and facilitating meetings.
- Problem solving and critical thinking skills.
- 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.
- Experience in data analysis or the interpretation of adverse experience information is a plus.
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:Assoc Prin. 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
Nearest Major Market: Philadelphia
Job Segment: Medical, Clinic, Risk Management, Safety, Manager, Healthcare, Finance, Management, Service