Merck Senior Scientist, CSRM Medical Assessment in Upper Gwynedd, Pennsylvania

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.

Medical Assessment:

In collaboration with the Clinical Safety and Risk Management (CSRM) Medical Assessment Physician, performs medical assessments of product quality observations / deviations. Works closely with colleagues in Merck Manufacturing Division (MMD) Product Quality and Global Safety & Environment during the investigation of product quality complaint reports and GMP non-compliance events to evaluate potential patient safety impact, prepare written reports and share findings at team meetings.

Safety Surveillance and Risk Management:

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 with direction/guidance from the senior CSRM Associate/Physician Assists the CSRM physician/management to: prepare responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for Merck products; strategizes with safety team recommending appropriate data to respond to queries and analyze data.

Education:

  • 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)

Required:

  • At least two years of clinical, pharmaceutical industry or related experience is required.

  • Excellent writing and communication skills a must.

Preferred:

  • 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.

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

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Job Drug/Dvcs Sfty Survnce (NonMD)

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

Title: Senior Scientist, CSRM Medical Assessment

Primary Location: NA-US-PA-Upper Gwynedd

Requisition ID: DRU000657