Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.
The CSRM Physician is a leader in pharmacovigilance and is responsible for the overall clinical risk management and safety surveillance of assigned investigational and marketed products. 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 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 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 medical associate and scientist.
May review and approve product labeling files stored in the safety database and demonstrates a working knowledge of MedDRA.
The CSRM Physician prepares safety summaries and analyses of safety related data for regulatory documents, aggregate reports, and summaries in support of regulatory filings
Qualifications, Skills & Experience
Required: MD, DO, or equivalent
Preferred: Board Certification
Required Experience and Skills:
Minimum 3 years clinical experience
Experience in drug development
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., 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.
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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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.
Search Firm Representatives Please Read Carefully
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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