Director, Clinical Safety & Risk Management (Vaccines/ID)

Upper Gwynedd, PA, US
October 12 2017
Organization Type
Requisition ID: DRU000648

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. 

Merck is well known forits many contributions to the prevention and control of infectious diseases, andcontinues as a global leader in vaccines, as well as antiviral, antibacterial,and anti-fungal therapeutic agents.  Under the general direction of an Executive Director in Clinical Safety and Risk Management, the CSRM Senior Principal Scientist is a leader in Drug and/or Vaccine Safety and is responsible for the overall Clinical Risk Management and Safety Surveillance of assigned investigational and marketed drugs/vaccines.

Key responsibilitiesinclude and are not limited to the following:

  • Support product development activities via RiskManagement and Safety Teams and Product Development Teams and otherrelated sub-team participation, including participation in internal andjoint internal/external research project teams relevant to the developmentof new compounds, and the further study of marketed compounds.
  • The CSRM Senior Principal Scientist may work closelywith a cross-functional group of experts in Epidemiology, RegulatoryAffairs, Statistics, and Manufacturing to manage safety topics underevaluation.
  • Duties include all aspects of Safety Data Evaluation,including assessing safety from a variety of sources, e.g. clinicaltrials, literature and post-approval use and ensuring completeness ofsafety information in worldwide package circulars.
  • Responsible for Safety Surveillance activities such assignaling reviews using medical judgment in review of individual cases aswell as overseeing the medical judgment of other staff.
  • Risk Management activities such as contributing torecommendations for PV actions and making recommendations for labeling.
  • Ensuring that the safety section of product circularsare medically and scientifically appropriate.
  • Analyzing and summarizing the findings from availablesafety data to support decisions.
  • The CSRM Senior Principal Scientist may supervise theactivities of CSRM Staff in the execution of safety data analysis andmedical writing.
  • Responsible for the development of worldwidepost-market risk management plans, pharmacovigilance strategies and riskminimizations activities as warranted
  • Contribute to medical presentations and scientificpublications
  • Interactions with public health authorities to supportthe safe and proper use of products
  • Qualifications


    • MD, DO, or equivalent


    • Minimum of (3) years Clinical experience after completing education
    • Minimum of (2) years industry experience in Clinical Research / Clinical Development and / or Drug Safety / Pharmacovigilance / Risk Management
    • Must have excellent written and verbal communication skills as well as analytical skills


  • 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

  • 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


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


                EEOC Poster

                EEOC GINA Supplement 

    HJ122017, HJ022018, LHH, LHMD18

    Job: Drug Safety Surveillance (MD)
    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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