at Merck in Dover, Delaware, United States
The CSRM Physician is a leader in pharmacovigilance and drug safety signal management. S/he is responsible for the overall clinical risk management and safety surveillance of assigned investigational and marketed products in the therapeutic areas of Vaccines & Infectious Diseases. As chairs of the Risk Management Safety Team (RMST), CSRM physicians lead the development and maintenance of risk management and pharmacovigilance plans.
Primary activities include, but are not limited to :
+ Engage directly in product development activities via core membership on Product Development Teams and chairmanship of the Risk Management and Safety Team (RMST), and other related sub-team participation, for assigned products. This may include participation in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds.
+ Partners with clinical development to ensure that clinical programs will support robust safety assessment of investigational compounds. Works with Clinical Research to develop the benefit-risk evaluation in aggregate safety reports.
+ The CSRM Physician works closely with cross-functional team members including those from clinical development, epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation and to ensure efforts are aligned to meet global pharmacovigilance and risk management strategies for assigned products.
+ Duties include all aspects of safety data evaluation, including assessing safety data from multiple sources, e.g. clinical trials, literature and post-approval use and ensuring completeness of safety information in company core data sheets (CCDS).
+ Accountable for scientific strategy for safety related documents (e.g. CTD components, Risk Management Plans (RMP) and Periodic Safety Update Reports (PSUR)) and for ensuring that the safety sections of Company product circulars are medically and scientifically appropriate.
+ Responsible for safety surveillance activities for assigned products such as aggregate clinical trial data analysis and post approval safety signaling reviews, using medical judgment in review of aggregate data and individual cases. Collaborates with CSRM Associate and Scientist in order to oversee all safety surveillance activities for assigned products.
+ Responsible for risk management activities such as contributing to recommendations for pharmacovigilance actions, making recommendations for labeling, and developing the RMPs, pharmacovigilance strategies and risk minimization activities as warranted in collaboration with CSRM Associate and Scientist.
+ The CSRM Physician prepares safety summaries and analyses of safety related data for regulatory documents, aggregate reports, and summaries in support of regulatory filings and may supervise the activities of CSRM medical associates and scientists in the execution of safety data analysis and authoring of regulatory documents.
+ Participates in the development, implementation and evaluation of standards, processes, metrics and other department initiatives.
+ Required: MD, DO, or equivalent
+ Preferred: Board Certification
Required Experience and Skills:
+ Minimum of 3 years clinical practice experience following residency OR additional post-graduate medical training (e.g. fellowship)
+ Prior experience in drug development (may include clinical development and/or regulatory affairs) or experience in clinical safety, pharmacovigilance and/or risk management
+ Demonstrated organizational leadership skills, preferably in the employment areas noted above.
+ Excellent communication, writing and analytic skills
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
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