Merck Clinical Safety Risk Management, Physician, Oncology in North Wales, Pennsylvania
The CSRM Physician is a leader in pharmacovigilance and is responsible for the overall clinical risk management and safety surveillance of assigned investigational and marketed products.
Key responsibilities include but are not limited to the following:
Engage directly in product development activities via core membership on Product Development Teams and chairmanship of the Risk Management and Safety Team (RMST), and other related sub-team participation, for assigned products. This may include participation in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds.
Partners with clinical development to ensure that clinical programs will support robust safety assessment of investigational compounds.
The CSRM Physician works closely with cross-functional team members including those from clinical development, epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation to ensure efforts are aligned to meet global pharmacovigilance and risk management strategies for assigned products.
Duties include all aspects of safety data evaluation, including assessing safety from multiple sources, e.g. clinical trials, literature and post-approval use.
Accountable for scientific strategy for safety related documents (e.g. CTD components, Risk Management Plans (RMP) and Periodic Safety Update Reports) and for ensuring that the safety sections of Company product circulars are medically and scientifically appropriate.
Responsible for safety surveillance activities such as aggregate clinical trial data analysis and post approval safety signaling reviews, using medical judgement in review of aggregate data and individual cases. Collaborate with CSRM Associate/scientist in order to oversee all safety surveillance activities for assigned products.
Responsible for the development of RMPs, pharmacovigilance strategies and risk minimization activities as warranted.
The CSRM Physician prepares safety summaries and analyses of safety related data for regulatory documents and aggregate reports and may supervise the activities of CSRM Staff in the execution of safety data analysis and authoring of regulatory documents.
Participates in the development, implementation and evaluation of standards, processes, metrics and other department initiatives.
Minimum Education Requirement:
- MD/DO or equivalent
Required Experience and Skills:
Minimum three (3) years clinical experience
Experience in clinical safety, pharmacovigilance and/or risk management
Must have excellent communication, writing and analytic skills
Oncology experience preferred
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:
Valid Driving License:
Number of Openings:
Requisition ID: R83858
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