Merck Organon - Senior Specialist, PV Quality & Compliance (Multiple Openings) in North Wales, Pennsylvania
Under the direction and oversight of the Pharmacovigilance (PV) Quality and Compliance Executive Director, the PV Quality and Compliance Senior Specialist maintains and performs the necessary processes to ensure high quality and compliant reporting of individual case and aggregate safety reports in accordance with PV
regulations. The Senior Specialist monitors the quality of individual case and aggregate safety reports and compliant reporting to ensure internal and regulatory compliance.
Perform quality review and compliance monitoring of individual case and aggregate safety reports to Health Authorities and Business Partners adhering to regulatory requirements.
Measure quality effectiveness by tracking appropriate metrics and evaluating key performance indicators.
Partner with internal and external stakeholders to identify, prioritize and monitor quality and compliance issues and develop solutions to minimize risk and ensure the overall quality management system.
Implement emerging regulations to ensure global alignment of quality and compliance activities and processes.
Assess the impact of internal procedural changes to quality and compliance monitoring activities and update of these activities to remain relevant.
Participate in various important pharmacovigilance processes, IT and quality initiatives.
Maintain procedural documents relevant to quality review and compliance activities.
Participate in inspection readiness activities and preparation as needed Assist in the review of responses to regulatory agency questions with regards to quality and compliance monitoring activities. Develop and maintain tools to streamline the monitoring of quality and compliance, introducing automation where possible.
Qualification, Skills & Experience
Bachelor's degree or master's degree in a life science/health care/pharmaceutical related field
Knowledge of PV principles, systems and requirements in addition to PV regulations
Strong analytical skills and quality focus
Problem solving, conflict resolution and critical thinking skills
Ability to function with a high degree of autonomy, quickly adapt to changes in business priorities and effectively manage competing priorities.
Proficient in basic Office 365 suite applications
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:
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Number of Openings:
Requisition ID: R81040
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