Merck Clinical Safety and Risk Management (CSRM) Medical Associate/Senior Scientist in Topeka, Kansas
Clinical Safety and Risk Management (CSRM) Medical Associate/Senior Scientist
Essential function(s) includes, but is not limited to:
Performs primary medical review of serious adverse experience reports and other AE reports of interest to monitor.
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 senior CSRM Associate/Physician.
Assists the CSRM physician/management to:
prepare responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for our Company's 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 managing the safety surveillance for assigned products. Accountable for overall safety profile of assigned products including information from registries and special programs.
Performs 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.
Working with the safety team to delegate appropriate activities related to pharmacovigilance to the scientists and providing medical input as appropriate.
Prepares responses to safety inquiries from health care professionals, regulatory agencies, subsidiary staff and other internal customers in conjunction with the CRM physician/management assigned to the product.
Develops working knowledge of pharmacovigilance and Risk Management Plans; begins to educate stakeholders outside or CSRM about risk management and role of CSRM.
Applies knowledge of safety profiles along with summary and analysis of safety related data in the regulatory documents such as Periodic Safety Update Reports (PSUR), Developmental Safety Update Reports (DSURs) and summaries in support of regulatory filings.
Mentoring and providing guidance to the scientists to conduct literature reviews. Core member of Risk Management Safety Team (RMST).
Represents CSRM on cross functional teams and committees as appropriate.
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.
Lead 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.
Participates in the development, implementation and evaluation of standards, processes, metrics and other department initiatives.
Assists in the preparation of manuscripts for submission to peer reviewed journals and gives poster and oral presentations at medical conferences on the safety profile of assigned products.
Assists with the guidance of these documents through the internal clearance and external submission process.
Position Qualifications :
Education Minimum Requirement:
- Master’s degree in nursing, PharmD, PA or other relevant clinical health related field.
Required Experience and Skills:
Clinically relevant medical experience in the undergraduate or graduate program is essential (e.g . nursing, pharm D, PA, or other relevant clinical health-related field).
At least two years of clinical, pharmaceutical industry or related experience is required.
Excellent writing and communication skills a must. Experience in data analysis or the interpretation of adverse experience information is a plus.
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 .
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Flexible Work Arrangements:
Flex Time, Remote Work, Telecommuting, Work Week
Valid Driving License:
Number of Openings:
Requisition ID: R110898