Merck Clinical Safety Risk Management Physician, Vaccines and Infectious Disease in Boston, Massachusetts
Under the general direction of an Executive Director in Clinical Safety and Risk Management, the CSRM Principal Scientist is a leader in Infectious Disease Drug and/or Vaccine Safety and is responsible for the overall Clinical Risk Management and Safety Surveillance of assigned investigational and marketed infectious disease 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 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 is 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.
Education Minimum Requirement:
- Required: MD, DO, or equivalent
Required Experience and Skills:
Minimum of (3) years Clinical experience after completing education
Must have excellent written and verbal communication skills as well as analytical skills
Preferred Experience and Skills:
Experience in Drug Safety, Pharmacovigilance and/or Risk Management 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
Infectious Disease or Vaccine experience preferred, but not required
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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.
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
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 - 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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OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf
We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
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.
Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
Requisition ID: R36781
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