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 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 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.
Duties include all aspects of Safety Data Evaluation, including assessing safety from a variety of sources, e.g. clinical trials, literature and post-approval use and ensuring completeness of safety information in worldwide package circulars.
Responsible for Safety Surveillance activities such as signaling reviews using medical judgment in review of individual cases as well as overseeing the medical judgment of other staff.
Risk Management activities such as contributing to recommendations for PV actions and making recommendations for labeling.
Ensuring that the safety section of our product circulars are medically and scientifically appropriate.
Analyzing and summarizing the findings from available safety data to support decisions.
The CSRM Senior Principal Scientist may supervise the activities of CSRM Staff in the execution of safety data analysis and medical writing.
Responsible for the development of worldwide post-market risk management plans, pharmacovigilance strategies and risk minimizations activities as warranted
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
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
To be considered for this position, please visit our career site at merck.com/careers, search jobs, create a profile and submit your resume for requisition # DRU000648 to: