Merck CSRM Senior Medical Associate in North Wales, Pennsylvania
Position Overview - Basic Functions & Responsibility
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 and describes the safety profile of assigned products; taking an active role in the oversight and development of pharmacovigilance and risk management plans under the overall direction of the CSRM physician/senior management. Leads preparation regulatory documents and responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for company marketed products; strategizes with safety team recommending appropriate data to respond to queries and analyze data.
Primary activities include, but are not limited to:
Independently working to expand and apply clinical, pharmacological, and epidemiologic knowledge and information technology skills to managing the safety surveillance for assigned products in consultation with CSRM physician.
Accountable for overall safety profile of assigned products including information from registries and special programs. Autonomously performing safety surveillance review of adverse experience reports as per SOP with the CSRM physician/management to monitor and describe 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 IT systems in order to investigate safety issues.
Working with the safety team to delegate appropriate activates related to Pharmacovigilance to the scientists and providing medical input as warranted.
Managing and preparing strategy for regulatory documents and 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.
Advanced Pharmacovigilance and Risk Management Plans knowledge and strong mentoring skills to educate stakeholders outside of CSRM and less experienced CSRM staff.
Advanced knowledge of safety profiles and capability in authoring specified sections of the Periodic Safety Update Reports (PSUR) and the Common Technical Document.
Mentoring and providing guidance to the medical associates and, core member of Risk Management Safety Team (RMST).
Assists the CSRM physician in leading project team and committees as appropriate.
Advanced skill in developing and evaluating Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS) for assigned products in consultation with the CSRM physician.
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.
Assists with the guidance of such publications through the internal clearance and external submission processes.
Strong leadership skills and subject matter expertise in specific departmental programs, SOPS, and departmental 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.
Master’s degree in nursing, PharmD, PA or other relevant clinical health related field.
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).
6-8 years of professional experience with both clinical and pharmaceutical industry experience required, of which a minimum of 3 years MUST include safety experience (e.g. PV or clinical) involving analysis of aggregate safety data and authoring of safety documents.
Excellent writing and communication skills a must.
Experience in data analysis or the interpretation of adverse experience information is a plus.
Demonstrated leadership skills in managing programs, processes, and facilitating meetings.
Problem solving and critical thinking 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.
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 - 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 an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
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Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
Requisition ID: R78128
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