Merck Clinical Safety and Risk Management CSRM Medical Associate / Senior Scientist in Rahway, New Jersey
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 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 team, 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 team 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 team to select and analyze the appropriate data from available IT systems in order to investigate safety issues. Working with the CSRM 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 CSRM team 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 CSRM 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 team 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. 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.
- Graduate degree in a relevant health related field (MSN, PharmD, PA) combined with an undergraduate degree in nursing (BSN), pharmacy, or other relevant clinical health related field.
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.
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.
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Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R62766
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