Organon - Associate Director, Pharmacovigilance Quality and Compliance ( MERCUSR81044ENUS)
Under the direction and oversight of the )Pharmacovigilance (PV) Quality and Compliance Executive Director, the Pharmacovigilance Quality and Compliance Associate Director develops and performs the necessary processes to ensure high quality and compliant reporting of individual case and aggregate safety reports in accordance with Pharmacovigilance regulations. The Associate Director is responsible for the implementation and optimization of processes used to monitor 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.
Responsible for the implementation of emerging regulations to ensure global alignment of quality and compliance activities and processes.
Collaborate with manufacturing quality to ensure robust and high quality interfaces between quality groups.
Assess the impact of internal procedural changes to quality and compliance monitoring activities and update of these activities to remain relevant.
Lead and participate in various important pharmacovigilance processes, IT and quality initiatives.
Responsible for ensuring that quality review and compliance activities are supported by robust procedures (E.g. Standard Operation Procedures, user manual, etc.)
Participate in inspection readiness activities and preparation as needed Act as a subject matter expert and provide input and 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
Minimum of 3 years of experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities
Knowledge of Pharmacovigilance principles, systems and requirements in addition to Pharmacovigilance regulations
Strong analytical skills and quality focus
Problem solving, conflict resolution and critical thinking skills
Experience working cross culturally and actively supporting diversity
Demonstrated ability to build and manage close relationships with key stakeholders
Ability to function with a high degree of autonomy, quickly adapt to changes in business priorities and effectively manage competing priorities.
Experience interacting with auditors/inspectors
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.
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.
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