Under the general direction of an Executive Director, Vaccines and Infectious Disease, the Clinical Safety and Risk Management (CSRM) Principal Scientist is a leader in drug safety and is responsible for overall clinical risk management and safety surveillance of assigned investigational and marketed drugs.
Key responsibilities include but 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 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 multiple 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 safety 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 pharmacovigilance actions and making recommendations for labeling.
Ensuring that the safety sections of Company product circulars are medically and scientifically appropriate.
Analyzing and summarizing the findings from available safety data to support decisions.
The CSRM 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.
Minimum of 3 years clinical experience
Excellent written and verbal communication skills as well as analytical skills
Drug safety, pharmacovigilance and/or risk management industry experience in both the investigational and post-approval environments
Board certification highly desirable
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., Kenilworth, 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
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy
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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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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Merck & Co., Inc.