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CSRM Medical Associate/Senior Scientist Oncology

at Merck in Dover, Delaware, United States

Job Description

Job Description

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

Due to Covid restrictions, this position is currently remote

Position Description:

Essential functions include, but are not limited to:

Performs primary medical review of serious adverse experience reports and other AE reports of interest to monitor and describes the safety profile of assigned products; taking an active role in the oversight and development of pharmacovigilance and risk management plans with direction/guidance from the Clinical Safety and Risk Management (CSRM) team.

Assists the CSRM team to: prepare responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for company products; strategizes with safety team recommending appropriate data to respond to queries and analyze data.

Primary activities include, but are not limited to:

+ In conjunction with the CSRM physician/management, works to expand and apply clinical, pharmacological, and epidemiologic knowledge and information technology skills to manage the safety surveillance for assigned products

+ Accountable for the overall safety profile of assigned products including information from registries and special programs

+ Completes safety surveillance review of adverse experience reports as per SOP with the CSRM physician/management in order to assist with the monitoring and description of the safety profile of assigned products and to identify and respond to safety issues

+ Works with CSRM physician/management to select and analyze the appropriate data from available IT systems in order to investigate safety issues

+ Prepares responses to safety inquiries from health care professionals, regulatory agencies, subsidiary staff and other internal customers in conjunction with the CSRM physician/management assigned to the product

+ Develops working knowledge of pharmacovigilance and Risk Management Plans; educates stakeholders outside of CSRM about risk management and the role of CSRM

+ Applies knowledge of safety profiles along with summary and analysis of safety related data in regulatory documents such as Periodic Safety Update Reports (PSUR), Developmental Safety Update Reports (DSURs) and summaries in support of regulatory filings

+ Core member of the Risk Management Safety Team (RMST), represents CSRM across functional teams and committees

+ Assists the CSRM physician/management with the development and evaluation of Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS) for assigned products

+ Leads communication and informational efforts to product teams regarding safety evaluation and risk management throughout clinical, submission and post-marketing phases

+ With minimal guidance, prepares manuscripts for submission to peer-reviewed journals; may give poster and/or oral presentations on the safety profiles of assigned products at medical conferences. Assists with the guidance of these documents through the internal clearance and external submission process

+ Participates in the development, implementation and evaluation of standards, processes, metrics and other department initiatives

Position Qualifications :

Education Minimum Requirement:

+ Undergraduate degree in nursing (BSN), pharmacy, Physician’s Assistant, or other relevant clinical health related field AND Graduate degree in a relevant health related field.ORGraduate degree in nursing (e.g MSN), PharmD, Physician’s Assistant, or other relevant clinical health related field (undergraduate training is flexible with advance degree in medical discipline)

Required Experience and Skills:

+ Two years of clinical, pharmaceutical industry or related experience is required.

+ Able to demonstrate strong writing and communication skills.

Preferred Experience and Skills:

+ Experience in data analysis and the interpretation of adverse experience information is a plus.

\#GRACJOBS

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.

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.

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.

Residents of Colorado

Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.

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.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please cl

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Job Posting: JC220677165

Posted On: Aug 07, 2022

Updated On: Aug 21, 2022