Clinical Safety Risk Management Physician

Date: May 8, 2019

Location: Upper Gwynedd, PA, US

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Requisition ID: DRU000889

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.


Under the general direction of a Clinical Safety and Risk Management (CSRM) Team Lead, the CSRM Principal Scientist is drug safety professional and is responsible for contributing to the overall Clinical Risk Management and Safety Surveillance of assigned investigational and marketed drugs / vaccines.


Key responsibilities include and are not limited to the following:

  • Support product development activities via Risk Management and Safety Teams and Product Development Teams and other related sub - team participation, including participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds.
  • The CSRM Senior Principal Scientist may work closely with a cross - functional group of experts in epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation to ensure efforts are aligned to meet our global pharmacovigilance and risk management strategies for assigned products.  
  • Duties include all aspects of safety data evaluation, including assessing safety from multiple sources, e.g. clinical trials, literature and post - approval use 
  • Responsible for scientific strategy for safety related documents (e.g. CTD components, RMPs and PBRERs) and for ensuring that the safety sections of Company product circulars are medically and scientifically appropriate.
  • Responsible for safety surveillance activities such as aggregate clinical trial data analysis and post approval safety signaling reviews, using medical judgment in review of summary data and individual cases as well as overseeing the medical judgment of other staff.
  • Responsible for the development of worldwide risk management plans, pharmacovigilance strategies and risk minimizations activities as warranted.
  • The CSRM Senior Principal Scientist may supervise the activities of CSRM Staff in the execution of safety data analysis and medical writing. 
  • Works with CSRM Group Lead to plan direction for function of the department, helps develop departmental and enterprise processes (as assigned). 
Qualifications

Education Minimum Requirement:
  • M.D., D.O., or equivalent
Required Experience and Skills:
  • Minimum of (3) years clinical experience after completing education
  • Must have excellent written and verbal communication skills as well as analytical skills
Preferred Experience and Skills:
  • Experience in Drug Safety, Pharmacovigilance and / or Risk Management Industry experience in both an Investigational and Post - Market capacity
  • Board certification highly desirable
  • Training and / or experience in Public Health, Epidemiology, and / or Quantitative Sciences 
  • Relevant Therapeutic Area experience preferred, but not required


Job: Drug Safety Surveillance (MD)
Other Locations: Rahway, NJ, US
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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