Associate Principal Scientist, CSRM Med Assessment Job

Employer
Merck
Location
Gwynedd, PA, US
Posted
October 12 2017
Discipline
Other
Organization Type
Pharma
Requisition ID: DRU000658

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 (AE) 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.

Qualifications

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: 

  • 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. Pharmacovigilance or Clinical Research) 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.

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.

  

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Drug/Dvcs Sfty Survnce (NonMD)
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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